Medical Device Manufacturer · JP , Hachiochi-Shi

Olympus Medical Systems Corp.

100 submissions · 100 cleared · Since 2012
100
Total
100
Cleared
0
Denied

Olympus Medical Systems Corp. — FDA 510(k) Submissions

Olympus Medical Systems Corp. has submitted 100 FDA 510(k) premarket notifications since 2012, of which 100 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bronchoscope (flexible Or Rigid), Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Duodenoscope And Accessories, Flexible/rigid, Biopsy Needle, Electrosurgical, Cutting & Coagulation & Accessories . Use the specialty filter in the sidebar to narrow results.

100 devices
1–25 of 100
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
K251807 · KGE Forceps, Biopsy, Electric · Gastroenterology & Urology
Mar 2026 267d
Single Use Distal Cover MAJ-2315 (MAJ-2315)
K253646 · FDT Duodenoscope And... · Gastroenterology & Urology
Feb 2026 94d
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)
K251336 · OWN Confocal Optical Imaging · General & Plastic Surgery
Nov 2025 196d
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
K252646 · FCG Biopsy Needle · Gastroenterology & Urology
Oct 2025 64d
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)
K250945 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Oct 2025 203d
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
K251867 · FDT Duodenoscope And... · Gastroenterology & Urology
Sep 2025 94d
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)
K250862 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Jun 2025 94d
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
K250701 · FDT Duodenoscope And... · Gastroenterology & Urology
Jun 2025 90d
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
K250573 · ODD Endoscopic Retrograde... · Gastroenterology & Urology
May 2025 90d
Disposable Distal Attachment D-201 Series
K250296 · FDS Gastroscope And... · Gastroenterology & Urology
May 2025 90d
Disposable Grasping Forceps FG-52D/FG-54D
K250263 · KTI Bronchoscope Accessory · Anesthesiology
Mar 2025 61d
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
K243807 · LQR Dislodger, Stone, Biliary · Gastroenterology & Urology
Mar 2025 97d
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)
K240617 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Jun 2024 90d
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
K221690 · FAJ Cystoscope And... · Gastroenterology & Urology
Dec 2022 202d
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K221660 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Dec 2022 203d
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
K221631 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Sep 2022 112d
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
K221638 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Sep 2022 105d
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K220587 · FDT Duodenoscope And... · Gastroenterology & Urology
May 2022 71d
4K UHD LCD Monitor OEV321UH
K220069 · GCJ Laparoscope, General &... · General & Plastic Surgery
Mar 2022 58d
Single Use Guide Sheath Kit-401, K-402
K212667 · EOQ Bronchoscope (flexible Or... · Anesthesiology
Sep 2021 30d
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
K201832 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Sep 2021 442d
Airway Mobilescope
K201300 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Jan 2021 256d
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
K201758 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Jan 2021 206d
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
K200342 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Dec 2020 310d
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K202661 · FDT Duodenoscope And... · General Hospital
Dec 2020 85d

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