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Olympus Medical Systems Corporation

Hachioji-Shi, JP · 73 510(k) clearances

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Total clearances
73
2020-01-17 → 2026-07-31
Last 12 months
23
Product codes
31
Most recent
2026-07-31
Name variants in FDA filings: Olympus Medical Systems Corporation / Olympus Medical Systems Corp.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EOQ Bronchoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 12 2026-04-23
FDT Duodenoscope And Accessories, Flexible/Rigid Class II Gastroenterology, Urology 6 2026-02-22
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Class II Gastroenterology, Urology 5 2026-06-24
EOB Nasopharyngoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 4 2026-03-20
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 3 2026-07-01
KNS — — — 3 2025-11-25
OCX — — — 3 2025-09-26
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Class II Gastroenterology, Urology 2 2026-07-31
PKL Hemostatic Metal Clip For The Gi Tract Class II Gastroenterology, Urology 2 2026-05-21
KGE Forceps, Biopsy, Electric Class II Gastroenterology, Urology 2 2026-03-06
OWN Confocal Optical Imaging Class II Gastroenterology, Urology 2 2025-11-12
FBK Endoscopic Injection Needle, Gastroenterology-Urology Class II Gastroenterology, Urology 2 2025-10-16
ITX — — — 2 2025-09-18
KTI Bronchoscope Accessory Class II Ear, Nose, Throat 2 2025-07-29
ODC Endoscope Channel Accessory Class II Gastroenterology, Urology 2 2025-07-16
FDF — — — 2 2025-05-15
FDS — — — 2 2025-05-01
IYN System, Imaging, Pulsed Doppler, Ultrasonic Class II Radiology 2 2025-01-17
FAJ Cystoscope And Accessories, Flexible/Rigid Class II Gastroenterology, Urology 2 2023-01-20
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 2 2022-03-09
FDX Endoscopic Cytology Brush Class II Gastroenterology, Urology 1 2025-12-18
FCG Biopsy Needle Class II Gastroenterology, Urology 1 2025-10-24
FGE Stents, Drains And Dilators For The Biliary Ducts Class II Gastroenterology, Urology 1 2025-10-21
BTG — — — 1 2025-06-12
ODD — — — 1 2025-05-27
LQR Dislodger, Stone, Biliary Class II Gastroenterology, Urology 1 2025-03-18
HIF Insufflator, Laparoscopic Class II Obstetrics/Gynecology 1 2025-01-13
HIH Hysteroscope (And Accessories) Class II Obstetrics/Gynecology 1 2022-09-02
HET Laparoscope, Gynecologic (And Accessories) Class II Obstetrics/Gynecology 1 2021-09-17
LFL Instrument, Ultrasonic Surgical Unclassified Unknown 1 2021-08-04
FEB Accessories, Cleaning, For Endoscope Class II Gastroenterology, Urology 1 2020-09-01
Filings

All 510(k) clearances (73)

Date K-number Device Code Class Specialty
2026-07-31 K261183 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) ODG Class II Gastroenterology, Urology
2026-07-01 K254056 THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) GEI Class II General, Plastic Surgery
2026-06-24 K261260 HD Camera Head OLYMPUS CH-S200-08-LB FET Class II Gastroenterology, Urology
2026-05-21 K260580 Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) PKL Class II Gastroenterology, Urology
2026-04-23 K252341 EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) EOQ Class II Ear, Nose, Throat
2026-03-20 K252050 Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D EOB Class II Ear, Nose, Throat
2026-03-06 K251807 Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR KGE Class II Gastroenterology, Urology
2026-02-22 K253646 Single Use Distal Cover MAJ-2315 (MAJ-2315) FDT Class II Gastroenterology, Urology
2025-12-18 K250993 Single Use Cytology Brush V (BC-V600P-3010) FDX Class II Gastroenterology, Urology
2025-11-25 K252889 Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) KNS — —
2025-11-12 K251336 VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) OWN Class II Gastroenterology, Urology
2025-10-24 K252646 Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) FCG Class II Gastroenterology, Urology
2025-10-21 K250409 Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) FGE Class II Gastroenterology, Urology
2025-10-17 K250945 Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) KNS — —
2025-10-16 K252247 Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) FBK Class II Gastroenterology, Urology
2025-10-10 K250351 Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) KNS — —
2025-10-07 K252150 Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) GEI Class II General, Plastic Surgery
2025-10-07 K250187 Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) KGE Class II Gastroenterology, Urology
2025-10-03 K251859 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) ODG Class II Gastroenterology, Urology
2025-09-26 K251986 AUXILIARY WATER TUBE MAJ-855 OCX — —
2025-09-25 K251997 Single-Use Biopsy Valve (MAJ-1555) OCX — —
2025-09-19 K251867 EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) FDT Class II Gastroenterology, Urology
2025-09-18 K250883 ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) ITX — —
2025-07-29 K251664 Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) KTI Class II Ear, Nose, Throat
2025-07-16 K250949 Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) ODC Class II Gastroenterology, Urology
2025-07-11 K250762 ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) ITX — —
2025-06-23 K250862 EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) EOQ Class II Ear, Nose, Throat
2025-06-12 K251279 Disposable Cytology Brush BC-202D/203D Series BTG — —
2025-06-05 K250701 Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) FDT Class II Gastroenterology, Urology
2025-06-04 K250118 Disposable Balloon Catheter B5-2C EOQ Class II Ear, Nose, Throat
2025-05-30 K250957 Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) EOQ Class II Ear, Nose, Throat
2025-05-27 K250573 Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M ODD — —
2025-05-15 K250432 Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) FDF — —
2025-05-01 K250296 Disposable Distal Attachment D-201 Series FDS — —
2025-03-31 K250263 Disposable Grasping Forceps FG-52D/FG-54D KTI Class II Ear, Nose, Throat
2025-03-19 K241842 Luer-Split MAJ-2092 ODC Class II Gastroenterology, Urology
2025-03-18 K243807 Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P LQR Class II Gastroenterology, Urology
2025-03-03 K243380 VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) EOB Class II Ear, Nose, Throat
2025-01-17 K243502 EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) IYN Class II Radiology
2025-01-13 K243527 High Flow Insufflation Unit (UHI-4) HIF Class II Obstetrics/Gynecology
2024-10-07 K242357 Water Container (MAJ-901); Water Container (MAJ-902) OCX — —
2024-07-03 K241371 VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) FET Class II Gastroenterology, Urology
2024-06-19 K232997 EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 FDS — —
2024-06-03 K240617 Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) PKL Class II Gastroenterology, Urology
2023-06-15 K222861 EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 EOQ Class II Ear, Nose, Throat
2023-04-26 K222584 EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 FET Class II Gastroenterology, Urology
2023-01-20 K221683 CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) FAJ Class II Gastroenterology, Urology
2022-12-29 K221690 OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) FAJ Class II Gastroenterology, Urology
2022-12-28 K221660 RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP EOB Class II Ear, Nose, Throat
2022-09-26 K221631 Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V EOQ Class II Ear, Nose, Throat
2022-09-19 K221638 Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 EOB Class II Ear, Nose, Throat
2022-09-02 K221557 Visera Hysterovideoscope Olympus HYF Type V HIH Class II Obstetrics/Gynecology
2022-05-11 K220587 Evis Exera III Duodenovideoscope Olympus TJF-Q190V FDT Class II Gastroenterology, Urology
2022-03-09 K220069 4K UHD LCD Monitor OEV321UH GCJ Class II Gastroenterology, Urology
2021-09-22 K212667 Single Use Guide Sheath Kit-401, K-402 EOQ Class II Ear, Nose, Throat
2021-09-17 K201832 Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 HET Class II Obstetrics/Gynecology
2021-08-04 K211838 Ultrasonic Bipolar Generator USG-410 with accessories LFL Unclassified Unknown
2021-01-26 K201300 Airway Mobilescope EOQ Class II Ear, Nose, Throat
2021-01-21 K201758 EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 EOQ Class II Ear, Nose, Throat
2020-12-17 K200342 Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L EOQ Class II Ear, Nose, Throat
2020-12-08 K202661 Evis Exera III Duodenovideoscope Olympus TJF-Q190V FDT Class II Gastroenterology, Urology
2020-11-09 K203128 EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS IYN Class II Radiology
2020-10-29 K202646 Visera Elite II Video System Center FET Class II Gastroenterology, Urology
2020-09-01 K201920 Endoscope Reprocessor OER-Elite FEB Class II Gastroenterology, Urology
2020-07-22 K201200 Visera Elite II Video System Center FET Class II Gastroenterology, Urology
2020-07-17 K200542 Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head OWN Class II Gastroenterology, Urology
2020-07-17 K192793 Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I FDF — —
2020-05-11 K192103 Thunderbeat Open Fine Jaw Type X Hand Instrument GEI Class II General, Plastic Surgery
2020-04-28 K192498 Single Use Injector FBK Class II Gastroenterology, Urology
2020-04-24 K200397 Single Use Biopsy Forceps FB-456D EOQ Class II Ear, Nose, Throat
2020-04-03 K193026 Visera Elite II Video System Center, Visera Elite II Endoeye 3D GCJ Class II Gastroenterology, Urology
2020-03-06 K192164 Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR EOQ Class II Ear, Nose, Throat
2020-01-17 K193182 Evis Exera III Duodenovideoscope Olympus TJF-Q190V FDT Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence