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Olympus Medical Systems Corp.

FDA 510(k) & PMA Approved Devices — 77 products

Total Devices77
Categories29
Latest Approval2026-04-23
TypeNumberDevice NameCodeDate
510(k) K252341 EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) EOQ 2026-04-23 View
510(k) K251807 Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR KGE 2026-03-06 View
510(k) K253646 Single Use Distal Cover MAJ-2315 (MAJ-2315) FDT 2026-02-22 View
510(k) 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 2025-11-12 View
510(k) K252646 Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) FCG 2025-10-24 View
510(k) 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 2025-10-17 View
510(k) K251867 EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) FDT 2025-09-19 View
510(k) 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 2025-06-23 View
510(k) K250701 Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) FDT 2025-06-05 View
510(k) K250573 Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M ODD 2025-05-27 View
510(k) K250296 Disposable Distal Attachment D-201 Series FDS 2025-05-01 View
510(k) K250263 Disposable Grasping Forceps FG-52D/FG-54D KTI 2025-03-31 View
510(k) K243807 Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P LQR 2025-03-18 View
510(k) 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 2024-06-03 View
510(k) K221690 OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) FAJ 2022-12-29 View
510(k) K221660 RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP EOB 2022-12-28 View
510(k) K221631 Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V EOQ 2022-09-26 View
510(k) K221638 Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 EOB 2022-09-19 View
510(k) K220587 Evis Exera III Duodenovideoscope Olympus TJF-Q190V FDT 2022-05-11 View
510(k) K220069 4K UHD LCD Monitor OEV321UH GCJ 2022-03-09 View
510(k) K212667 Single Use Guide Sheath Kit-401, K-402 EOQ 2021-09-22 View
510(k) K201832 Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 HET 2021-09-17 View
510(k) K201300 Airway Mobilescope EOQ 2021-01-26 View
510(k) K201758 EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 EOQ 2021-01-21 View
510(k) 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 2020-12-17 View
510(k) K202661 Evis Exera III Duodenovideoscope Olympus TJF-Q190V FDT 2020-12-08 View
510(k) K203128 EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS IYN 2020-11-09 View
510(k) K202646 Visera Elite II Video System Center FET 2020-10-29 View
510(k) K201920 Endoscope Reprocessor OER-Elite FEB 2020-09-01 View
510(k) K201200 Visera Elite II Video System Center FET 2020-07-22 View
510(k) 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 2020-07-17 View
510(k) 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 2020-07-17 View
510(k) K192103 Thunderbeat Open Fine Jaw Type X Hand Instrument GEI 2020-05-11 View
510(k) K192498 Single Use Injector FBK 2020-04-28 View
510(k) K200397 Single Use Biopsy Forceps FB-456D EOQ 2020-04-24 View
510(k) K193026 Visera Elite II Video System Center, Visera Elite II Endoeye 3D GCJ 2020-04-03 View
510(k) K192164 Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR EOQ 2020-03-06 View
510(k) K193182 Evis Exera III Duodenovideoscope Olympus TJF-Q190V FDT 2020-01-17 View
510(k) K193039 Single Use Balloon Dilator V (with knife) KNS 2019-12-17 View
510(k) K190239 Single Use Aspiration Needle KTI 2019-12-10 View
510(k) K190772 SURGICAL MICROSCOPE SYSTEM ORBEYE with IR IZI 2019-10-10 View
510(k) K183416 Rhino-Laryngo Videoscope Olympus ENF-VT3 EOB 2019-09-06 View
510(k) K183525 EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F PSV 2019-09-06 View
510(k) K183419 EVIS EXERA III Bronchovideoscope Olympus BF-XT190 EOQ 2019-09-05 View
510(k) K190449 Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head FET 2019-08-30 View
510(k) K190293 Single Use Cytology Brush BC-205D BTG 2019-08-02 View
510(k) K183590 Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip PKL 2019-08-01 View
510(k) K190969 ENDOSCOPE REPROCESSOR OER-Elite FEB 2019-07-09 View
510(k) K182408 Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 KNS 2019-05-15 View
510(k) K183053 Olympus Small Intestinal Capsule Endoscope System NEZ 2019-03-05 View
510(k) K182102 RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 EOB 2019-02-06 View
510(k) K181451 URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R FGB 2019-01-16 View
510(k) K173495 Single Use Hot Biopsy Forceps FD-231 QEC 2018-11-30 View
510(k) K180668 Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N FCG 2018-11-15 View
510(k) K181994 Single Use Aspiration Needle NA-U201H FCG 2018-10-31 View
510(k) K181240 Rhino-Laryngo Fiberscope Olympus ENF-GP2 EOB 2018-10-04 View
510(k) K180575 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X GEI 2018-07-12 View
510(k) K180449 Single Use Aspiration Needle NA-U200H FCG 2018-06-08 View
510(k) K172726 EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D EOQ 2018-04-30 View
510(k) K172610 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S GEI 2018-04-17 View
510(k) K172246 OLYMPUS URF-V2/V2R FGB 2018-03-30 View
510(k) K172298 OLYMPUS URF-P6/P6R FGB 2018-03-29 View
510(k) K173459 Olympus Small Intestinal Capsule Endoscope System NEZ 2018-03-13 View
510(k) K172734 Single Use Electrosurgical Snare SD-400 FDI 2017-12-07 View
510(k) K172618 SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 GCJ 2017-12-05 View
510(k) K170811 Single Use Retrieval Nitinol Basket V LQR 2017-11-27 View
510(k) K171158 Single Use Electrosurgical knife KNS 2017-11-17 View
510(k) K172817 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA FET 2017-10-17 View
510(k) K171916 Single Use Hot Biopsy Forceps FD-231 KGE 2017-10-13 View
510(k) K172691 Ultrasonic Generator LFL 2017-10-04 View
510(k) K163069 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM NEZ 2017-01-19 View
510(k) K153773 Disposal Lens Cleaning Sheath GCJ 2016-11-22 View
510(k) K160098 Single Use Aspiration Needle NA-U401SX FCG 2016-03-22 View
510(k) K160241 Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 KNS 2016-03-02 View
510(k) K151743 THUNDERBEAT Open Fine Jaw GEI 2016-02-26 View
510(k) K153625 Single Use Injector NM600/610 FBK 2016-02-12 View
510(k) K143153 EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V FDT 2016-01-15 View
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