Chrysalis Intelligence · Sponsors · STERIS Corporation

STERIS Corporation

Mentor, OH, US · 79 510(k) clearances · 47 recalls

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Total clearances
79
2020-01-27 → 2026-06-24
Last 12 months
5
Product codes
25
Most recent
2026-06-24
Name variants in FDA filings: STERIS Corporation / Steris
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FRC Indicator, Biological Sterilization Process Class II General Hospital 13 2026-04-08
JOJ — — — 11 2025-05-02
ODC Endoscope Channel Accessory Class II Gastroenterology, Urology 7 2024-11-08
MED — — — 6 2026-04-08
FLE Sterilizer, Steam Class II General Hospital 5 2026-06-24
NZA — — — 5 2023-10-03
NVE Washer, Cleaner, Automated, Endoscope Class II Gastroenterology, Urology 4 2022-09-30
MLR Sterilizer, Chemical Class II General Hospital 3 2023-10-20
FGB — — — 3 2023-07-25
PKL Hemostatic Metal Clip For The Gi Tract Class II Gastroenterology, Urology 2 2025-04-18
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 2 2025-04-15
FEB Accessories, Cleaning, For Endoscope Class II Gastroenterology, Urology 2 2024-12-02
OVY — — — 2 2023-12-15
FRG Wrap, Sterilization Class II General Hospital 2 2023-08-07
GEH Unit, Cryosurgical, Accessories Class II General, Plastic Surgery 2 2022-12-02
SHM Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe Class II General Hospital 1 2026-05-01
SDC Qualitative Cleaning Process Protein Indicator Class II General Hospital 1 2024-11-12
FBK Endoscopic Injection Needle, Gastroenterology-Urology Class II Gastroenterology, Urology 1 2024-03-08
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class II General Hospital 1 2023-08-07
FEQ Pump, Air, Non-Manual, For Endoscope Class II Gastroenterology, Urology 1 2022-03-11
QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator Class II General Hospital 1 2022-01-07
FDI Snare, Flexible Class II Gastroenterology, Urology 1 2021-10-07
ODD — — — 1 2020-11-06
DWJ System, Thermal Regulating Class II Cardiovascular 1 2020-06-13
OCU Endoscopic Storage Cover Class II Gastroenterology, Urology 1 2020-01-27
Safety

Recalls (47)

Class I (serious)
0
Risk of injury / death
Total recalls
47
Currently ongoing
23
Most recent
2026-05-15
DateSeverityStatusRecall # ProductCodeReason
2026-05-15 Class II Ongoing Z-2450-2026 ALYON Surgical Lighting System — The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
2026-05-15 Class II Ongoing Z-2449-2026 HarmonyAIR A-Series Surgical Lighting System — The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
2026-05-15 Class II Ongoing Z-2448-2026 HarmonyAIR A-Series Surgical Lighting System — There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
2025-11-19 Class II Ongoing Z-0910-2026 AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfec… — Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within th…
2025-11-19 Class II Ongoing Z-0909-2026 AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfect… — Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within th…
2025-06-23 Class II Ongoing Z-2178-2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems — The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be exp…
2025-06-23 Class II Ongoing Z-2177-2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems — The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be exp…
2025-05-23 Class II Ongoing Z-1361-2026 Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H — This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the…
2024-06-13 Class II Ongoing Z-2539-2024 Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated… — IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or par…
2024-06-13 Class II Ongoing Z-2538-2024 Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus… — IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or par…
2024-06-13 Class II Ongoing Z-2537-2024 Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus… — IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or par…
2024-06-13 Class II Ongoing Z-2536-2024 Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" A… — IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or par…
2023-12-12 Class II Ongoing Z-0984-2024 Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 — Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or…
2023-12-12 Class II Ongoing Z-0983-2024 Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 — Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or…
2023-11-16 Class II Ongoing Z-0737-2024 V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intende… — Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scisso…
2023-11-13 Class II Ongoing Z-0617-2024 Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors … — Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able …
2023-04-10 Class II Ongoing Z-1595-2023 Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 — In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malf…
2023-03-17 Class II Ongoing Z-1476-2023 Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, sing… — Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field …
2023-03-17 Class II Ongoing Z-1475-2023 Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including di… — Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field …
2022-12-12 Class II Ongoing Z-0781-2023 VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and ro… — Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , som…
2022-12-12 Class II Ongoing Z-0780-2023 VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and rou… — Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , som…
2022-12-12 Class II Ongoing Z-0779-2023 VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in install… — Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , som…
2022-12-12 Class II Ongoing Z-0778-2023 VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installa… — Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , som…
2022-10-17 Class II Terminated Z-0241-2023 GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coag… — Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the…
2022-09-02 Class II Terminated Z-0079-2023 Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 — The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a …
2022-04-22 Class II Terminated Z-1256-2022 Reliance Synergy Washer/Disinfector — The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the dryin…
2022-03-22 Class II Terminated Z-1119-2022 Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Mo… — Product not approved for release for US distribution
2022-03-22 Class II Terminated Z-1118-2022 Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Num… — Product not approved for release for US distribution
2021-01-21 Class II Terminated Z-1149-2021 OT1000 Series Orthopedic Surgical Tables — On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unex…
2020-12-11 Class II Terminated Z-0876-2021 Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate lev… — The electrical contactor component present in the drying chamber of the Reliance Vision Single-Chamber Washer/Disinfector may malfunction, potentially leading t…
2020-12-02 Class II Terminated Z-0799-2021 Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0798-2021 Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0797-2021 Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0796-2021 Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0795-2021 Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0794-2021 Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0793-2021 Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0792-2021 Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0791-2021 Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0790-2021 Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0789-2021 Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0788-2021 Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-12-02 Class II Terminated Z-0787-2021 Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881041 — Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam processing causing cosmetic defects on the exterior of the pouc…
2020-12-02 Class II Terminated Z-0786-2021 Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031 — Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the po…
2020-11-19 Class II Terminated Z-0830-2021 Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instrum… — STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause t…
2020-10-07 Class III Terminated Z-0458-2021 Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible … — Potential for cleaning solution intrusion into endoscope
2020-06-26 Class II Terminated Z-2700-2020 InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STER… — A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Filings

All 510(k) clearances (79)

Date K-number Device Code Class Specialty
2026-06-24 K261055 AMSCO 700 Steam Sterilizer FLE Class II General Hospital
2026-05-01 DEN240075 Prolystica Pass Thru Disinfectant Wipes SHM Class II General Hospital
2026-04-08 K260766 Celerity 5 HP Biological Indicator (LCB052) FRC Class II General Hospital
2026-04-08 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 MED — —
2025-09-24 K252680 Celerity™ 20 HP Biological Indicator FRC Class II General Hospital
2025-06-06 K251452 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) FRC Class II General Hospital
2025-05-02 K251048 Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 JOJ — —
2025-04-25 K243876 VERIFY STEAM Integrating Indicator JOJ — —
2025-04-18 K250842 PADLOCK CLIP EFTR Kit (00713229) PKL Class II Gastroenterology, Urology
2025-04-15 K242773 Electro Lube NXT GEI Class II General, Plastic Surgery
2025-02-06 K250061 Celerity Incubator FRC Class II General Hospital
2025-02-06 K250044 Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) FRC Class II General Hospital
2024-12-04 K243475 Chemical Indicator for enspire CLCSPS (LCC015) JOJ — —
2024-12-02 K243433 enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System FEB Class II Gastroenterology, Urology
2024-11-12 DEN230085 VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator SDC Class II General Hospital
2024-11-08 K243075 Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) ODC Class II Gastroenterology, Urology
2024-10-11 K242742 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) ODC Class II Gastroenterology, Urology
2024-09-17 K240274 PADLOCK CLIP EFTR Kit (00713229) PKL Class II Gastroenterology, Urology
2024-08-20 K242189 CELERITY HP Indicator Tape (PCC077) JOJ — —
2024-06-11 K241344 MetriCide™ OPA Plus Solution Test Strip JOJ — —
2024-05-31 K241055 Electro Lube NXT GEI Class II General, Plastic Surgery
2024-04-17 K240032 Celerity Chemical Indicator for enspire 3000 CLCSPS JOJ — —
2024-04-10 K240760 CELERITY HP Indicator Tape JOJ — —
2024-03-08 K232826 Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) FBK Class II Gastroenterology, Urology
2024-03-06 K240352 Defendo Single Use Cleaning Adapter for Olympus Endoscopes ODC Class II Gastroenterology, Urology
2024-02-09 K240098 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) ODC Class II Gastroenterology, Urology
2023-12-15 K233682 VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE OVY — —
2023-12-15 K233681 ConFirm 20 Minute Incubator FRC Class II General Hospital
2023-12-08 K233654 VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems JOJ — —
2023-10-27 K233187 Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) JOJ — —
2023-10-20 K233065 V-PRO maX 2 Low Temperature Sterilization System MLR Class II General Hospital
2023-10-20 K232951 BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) ODC Class II Gastroenterology, Urology
2023-10-03 K232918 enspire 300 Series Automated Endoscope Reprocessor NZA — —
2023-10-03 K232914 SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) MED — —
2023-09-13 K232485 AMSCO 600 Steam Sterilizer FLE Class II General Hospital
2023-09-11 K231746 VERIFY Spore Test Strip for S40 Sterilant Concentrate OVY — —
2023-08-07 K231501 PRO-LITE Sterilization Tray KCT Class II General Hospital
2023-08-07 K231500 Vis-U-All Low Temperature Sterilization Pouches FRG Class II General Hospital
2023-08-07 K231490 Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator FRC Class II General Hospital
2023-08-07 K231488 Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape JOJ — —
2023-08-07 K223476 V-PRO maX 2 Low Temperature Sterilization System MLR Class II General Hospital
2023-07-25 K231878 Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 FGB — —
2023-07-21 K230560 enspire 300 Series Automated Endoscope Reprocessor System NZA — —
2023-07-17 K230558 Revital-Ox PAA High Level Disinfectant Chemical Indicator JOJ — —
2023-06-30 K230930 enspire 3000 Cleaning and Liquid Chemical Sterile Processing System FEB Class II Gastroenterology, Urology
2023-06-15 K223717 Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack FRC Class II General Hospital
2023-06-15 K223715 Celerity Incubator FRC Class II General Hospital
2023-03-28 K230582 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 MED — —
2023-02-17 K223466 Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 FGB — —
2022-12-02 K223369 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 GEH Class II General, Plastic Surgery
2022-09-30 K222849 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector NVE Class II Gastroenterology, Urology
2022-09-28 K222615 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate MED — —
2022-09-09 K222440 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays FRG Class II General Hospital
2022-09-09 K222093 V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System MLR Class II General Hospital
2022-08-25 K222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector NVE Class II Gastroenterology, Urology
2022-08-18 K222272 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 GEH Class II General, Plastic Surgery
2022-07-21 K213881 Celerity Incubator FRC Class II General Hospital
2022-03-18 K220473 CELERITY 20 HP Challenge Pack FRC Class II General Hospital
2022-03-11 K220395 EndoGator Endoscopy Irrigation Tubing FEQ Class II Gastroenterology, Urology
2022-03-10 K220361 Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide NZA — —
2022-01-07 K213262 CELERITY HP Chemical Indicator QKM Class II General Hospital
2021-11-23 K211347 Uretero1 Ureteroscope System FGB — —
2021-10-28 K212424 AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers FLE Class II General Hospital
2021-10-07 K212860 SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) FDI Class II Gastroenterology, Urology
2021-09-07 K211607 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate MED — —
2021-09-03 K210342 BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor ODC Class II Gastroenterology, Urology
2021-08-25 K211500 AMSCO 600 Medium Steam Sterilizer FLE Class II General Hospital
2021-05-12 K210737 SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate MED — —
2021-01-28 K203223 Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide NZA — —
2021-01-14 K202104 BioGuard EUS Air/Water and Suction Valves ODC Class II Gastroenterology, Urology
2021-01-08 K202721 Celerity 20 Steam Biological Indicator for IUSS FRC Class II General Hospital
2020-12-01 K203199 RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector NVE Class II Gastroenterology, Urology
2020-11-06 K203061 Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) FLE Class II General Hospital
2020-11-06 K202583 BioShield biopsy valve EUS - Linear ODD — —
2020-06-13 K200446 STERIS Patient Warming System DWJ Class II Cardiovascular
2020-05-22 K200126 VERIFY Assert Self-Contained Biological Indicator FRC Class II General Hospital
2020-05-14 K200989 Reliance Endoscope Processing System NZA — —
2020-04-03 K200577 RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector NVE Class II Gastroenterology, Urology
2020-01-27 K191715 Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile OCU Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence