Chrysalis Intelligence · Sponsors · Intuitive Surgical, Inc.

Intuitive Surgical, Inc.

Sunnyvale, CA, US · 76 510(k) clearances · 75 recalls (1 Class I)

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Total clearances
76
2020-02-06 → 2026-08-07
Last 12 months
18
Product codes
7
Most recent
2026-08-07
Name variants in FDA filings: Intuitive Surgical / Intuitive Surgical, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NAY System, Surgical, Computer Controlled Instrument Class II Gastroenterology, Urology 54 2026-07-31
EOQ Bronchoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 9 2025-09-23
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 5 2026-07-14
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 4 2024-08-05
QIH Automated Radiological Image Processing Software Class II Radiology 2 2025-12-16
FDS — — — 1 2026-08-07
GAG — — — 1 2025-03-10
Safety

Recalls (75)

Class I (serious)
1
Risk of injury / death
Total recalls
75
Currently ongoing
72
Most recent
2026-04-02
DateSeverityStatusRecall # ProductCodeReason
2026-04-02 Class II Ongoing Z-2046-2026 Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4… — Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
2026-03-11 Class I Ongoing Z-1855-2026 Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 — Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
2025-12-30 Class II Ongoing Z-1355-2026 da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 — Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perc…
2025-12-15 Class II Ongoing Z-1096-2026 da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1… — Access Port System tray may develop cracks potentially resulting in a sterility breach.
2025-12-09 Class II Ongoing Z-1701-2026 Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instru… — Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
2025-12-09 Class II Ongoing Z-1700-2026 Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Mode… — Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
2025-12-09 Class II Ongoing Z-1699-2026 Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Mo… — Due to increased complaints for broken/frayed grip cables for reusable instruments.
2025-12-09 Class II Ongoing Z-1698-2026 Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Mo… — Due to increased complaints for broken/frayed grip cables for reusable instruments.
2025-12-09 Class II Ongoing Z-1697-2026 Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Graspe… — Due to increased complaints for broken/frayed grip cables for reusable instruments.
2025-12-09 Class II Ongoing Z-1696-2026 Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scisso… — Due to increased complaints for broken/frayed grip cables for reusable instruments.
2025-12-04 Class II Ongoing Z-1134-2026 Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: … — Due to probe bags that may have a compromised or incomplete sterile pouch seal.
2025-11-17 Class II Ongoing Z-1428-2026 Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery. — An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or t…
2025-11-07 Class II Ongoing Z-1232-2026 Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number:… — Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to b…
2025-02-26 Class II Ongoing Z-1325-2025 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software V… — Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
2024-12-19 Class II Ongoing Z-0924-2025 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wi… — Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
2024-12-19 Class II Ongoing Z-0923-2025 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of proced… — Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
2024-12-19 Class II Ongoing Z-0883-2025 8MM,FORCE BIPOLAR,IS4000 REF 471405 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0882-2025 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0881-2025 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0880-2025 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0879-2025 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0878-2025 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0877-2025 8MM,COBRA GRASPER,IS4000 REF 471190 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0876-2025 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0875-2025 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0874-2025 8MM,PROGRASP FORCEPS,IS4000 REF 471093 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0873-2025 8MM,CADIERE FORCEPS,IS4000 REF 471049 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0872-2025 8MM,LONG TIP FORCEPS,IS4000 REF 471048 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0871-2025 8MM,FORCE BIPOLAR,IS4000 REF 470405 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0870-2025 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0869-2025 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0868-2025 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0867-2025 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0866-2025 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0865-2025 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0864-2025 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0863-2025 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0862-2025 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0861-2025 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0860-2025 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0859-2025 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0858-2025 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0857-2025 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0856-2025 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0855-2025 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0854-2025 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0853-2025 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0852-2025 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0851-2025 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0850-2025 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0849-2025 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0848-2025 8MM, POTTS SCISSORS, IS4000 REF 470001 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-12-19 Class II Ongoing Z-0847-2025 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
2024-08-21 Class II Ongoing Z-0964-2026 da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40 — Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer,…
2024-07-12 Class II Ongoing Z-2720-2024 Ion Endoluminal System, REF: 380748-65 — There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a…
2024-03-13 Class II Ongoing Z-1518-2024 Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 — Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause…
2023-10-06 Class II Ongoing Z-0406-2024 Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm — There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
2023-06-12 Class II Ongoing Z-2059-2023 da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 — Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragme…
2023-02-10 Class II Ongoing Z-1293-2023 da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 — Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specification…
2023-01-24 Class II Ongoing Z-1262-2023 Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Pa… — Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk…
2022-10-07 Class II Ongoing Z-0340-2023 INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 … — Potential staple deployment failure and device fragment generation
2022-09-20 Class II Ongoing Z-0133-2023 da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSC… — Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force …
2022-07-01 Class II Ongoing Z-1460-2022 Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Sma… — Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
2022-07-01 Class II Ongoing Z-1459-2022 Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Sma… — Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
2022-06-22 Class II Ongoing Z-1484-2022 The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and … — Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and…
2022-03-17 Class II Ongoing Z-0999-2022 da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinic… — As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within …
2022-03-03 Class II Ongoing Z-1210-2022 DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440 — Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
2022-03-03 Class II Ongoing Z-1209-2022 VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422 — Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
2021-12-23 Class II Ongoing Z-0702-2022 da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 — Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the …
2021-09-22 Class II Ongoing Z-0419-2022 da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874… — Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver …
2021-09-21 Class II Terminated Z-0275-2022 The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (S… — Incorrect expiration date on its package labeling (shipper box and inner carton label).
2021-08-06 Class II Terminated Z-0106-2022 Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI… — Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
2020-10-23 Class II Terminated Z-0489-2021 Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulat… — The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
2020-06-10 Class II Ongoing Z-2950-2020 ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter R… — One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Cath…
2020-06-10 Class II Ongoing Z-2949-2020 Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845. — One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Cath…
Filings

All 510(k) clearances (76)

Date K-number Device Code Class Specialty
2026-08-07 K253702 Intuitive Endoluminal Gastrointestinal System (IG1000) FDS — —
2026-07-31 K261824 da Vinci Surgical System, Model IS5000 NAY Class II Gastroenterology, Urology
2026-07-14 K261249 Universal Seal (5-12 mm) GCJ Class II Gastroenterology, Urology
2026-05-22 K260695 da Vinci Firefly Imaging System NAY Class II Gastroenterology, Urology
2026-03-11 K253986 da Vinci Force Feedback Instruments NAY Class II Gastroenterology, Urology
2026-02-24 K253978 Universal Seal (5-12 mm) GCJ Class II Gastroenterology, Urology
2026-01-16 K253556 da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator NAY Class II Gastroenterology, Urology
2026-01-16 K251739 da Vinci Surgical System (IS5000) NAY Class II Gastroenterology, Urology
2025-12-16 K251763 IRISeg QIH Class II Radiology
2025-12-15 K252675 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2025-12-02 K252069 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2025-10-03 K251426 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2025-09-23 K252045 Ion Endoluminal System (IF1000) EOQ Class II Ear, Nose, Throat
2025-09-10 K251817 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2025-09-08 K251227 da Vinci Surgical System (IS5000) NAY Class II Gastroenterology, Urology
2025-09-05 K252528 Ion Endoluminal System (IF1000) EOQ Class II Ear, Nose, Throat
2025-08-29 K251324 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2025-08-28 K252350 da Vinci SP Firefly Imaging System NAY Class II Gastroenterology, Urology
2025-07-29 K250442 da Vinci Surgical System, IS5000 NAY Class II Gastroenterology, Urology
2025-07-23 K251213 Da Vinci Surgical System (IS5000) NAY Class II Gastroenterology, Urology
2025-07-16 K251202 da Vinci Surgical System (IS5000) NAY Class II Gastroenterology, Urology
2025-07-02 K251490 8 mm Assist Cannula; 12 mm Assist Cannula GCJ Class II Gastroenterology, Urology
2025-06-13 K250674 Vessel Sealer Curved (480522) NAY Class II Gastroenterology, Urology
2025-06-11 K240852 da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) NAY Class II Gastroenterology, Urology
2025-05-13 K250786 SP Endoscope, 0° (430600) NAY Class II Gastroenterology, Urology
2025-04-24 K243714 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2025-04-01 K242427 da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) NAY Class II Gastroenterology, Urology
2025-03-10 K243596 da Vinci SP SureForm 45 Staplers and Reloads (SP1098) GAG — —
2025-02-28 K243582 da Vinci SP Advanced Access Port Kit (432701) NAY Class II Gastroenterology, Urology
2024-12-16 K243641 da Vinci Surgical System (IS5000) NAY Class II Gastroenterology, Urology
2024-12-10 K242461 IRISeg QIH Class II Radiology
2024-11-26 K242318 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2024-11-18 K241814 da Vinci SP Instruments (SP1098) NAY Class II Gastroenterology, Urology
2024-09-24 K242070 Ion Endoluminal System (IF 1000) EOQ Class II Ear, Nose, Throat
2024-09-10 K241638 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads NAY Class II Gastroenterology, Urology
2024-08-05 K241635 da Vinci E-200 Electrosurgical Generator GEI Class II General, Plastic Surgery
2024-08-05 K241360 Universal Seal (5-12 mm) GCJ Class II Gastroenterology, Urology
2024-08-02 K241621 Da Vinci Monopolar and Bipolar Adapters (378896) GEI Class II General, Plastic Surgery
2024-07-08 K240502 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2024-07-03 K241284 da Vinci Surgical System (IS5000) NAY Class II Gastroenterology, Urology
2024-06-04 K232773 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2024-05-24 K240723 da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) NAY Class II Gastroenterology, Urology
2024-04-03 K240135 Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) EOQ Class II Ear, Nose, Throat
2024-03-14 K232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation NAY Class II Gastroenterology, Urology
2023-12-18 K232984 Ion Endoluminal System (IF1000) EOQ Class II Ear, Nose, Throat
2023-11-08 K231798 da Vinci SP Surgical System NAY Class II Gastroenterology, Urology
2023-07-05 K231358 Universal Seal (5-12 mm) GCJ Class II Gastroenterology, Urology
2023-06-21 K231212 da Vinci E-200 Electrosurgical Generator GEI Class II General, Plastic Surgery
2023-05-12 K231224 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) NAY Class II Gastroenterology, Urology
2023-04-05 K230033 Da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2023-03-16 K222839 EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System NAY Class II Gastroenterology, Urology
2022-11-28 K223039 da Vinci E-200 Electrosurgical Generator GEI Class II General, Plastic Surgery
2022-11-22 K223080 da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) NAY Class II Gastroenterology, Urology
2022-10-20 K222827 da Vinci Firefly Imaging System NAY Class II Gastroenterology, Urology
2022-08-15 K214095 da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments NAY Class II Gastroenterology, Urology
2022-06-16 K220299 Ion Endoluminal System (IF1000) EOQ Class II Ear, Nose, Throat
2022-02-17 K213710 da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System NAY Class II Gastroenterology, Urology
2022-01-31 K220023 8mm Monopolar Curved Scissors NAY Class II Gastroenterology, Urology
2021-12-10 K211997 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads NAY Class II Gastroenterology, Urology
2021-11-23 K212101 da Vinci SP Firefly Imaging System NAY Class II Gastroenterology, Urology
2021-09-29 K212747 Da Vinci SP Surgical System NAY Class II Gastroenterology, Urology
2021-08-26 K212048 Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) EOQ Class II Ear, Nose, Throat
2021-08-06 K211784 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) NAY Class II Gastroenterology, Urology
2021-07-23 K211316 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2021-06-23 K211595 da Vinci SP Surgical System (SP1098) NAY Class II Gastroenterology, Urology
2021-04-26 K210918 da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System NAY Class II Gastroenterology, Urology
2021-02-10 K203632 da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments NAY Class II Gastroenterology, Urology
2020-12-22 K202968 Da Vinci SP Surgical System NAY Class II Gastroenterology, Urology
2020-12-10 K202834 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) NAY Class II Gastroenterology, Urology
2020-11-16 K202370 Ion Endoluminal System EOQ Class II Ear, Nose, Throat
2020-11-12 K202571 da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories NAY Class II Gastroenterology, Urology
2020-09-28 K192717 da Vinci SP Surgical System NAY Class II Gastroenterology, Urology
2020-06-26 K201146 Ion Endoluminal System EOQ Class II Ear, Nose, Throat
2020-04-29 K192803 da Vinci Xi Surgical System, da Vinci X Surgical System NAY Class II Gastroenterology, Urology
2020-03-31 K183086 da Vinci X and Xi Surgical System NAY Class II Gastroenterology, Urology
2020-02-06 K191529 da Vinci Xi Surgical System, da Vinci X Surgical System NAY Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence