Medical Device Manufacturer · JP , Hachiochi-Shi

Olympus Medical Systems Corp. - FDA 510(k) Cleared Devices

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

FDA 510(k) cleared devices by Olympus Medical Systems Corp. Gastroenterology & Urology

50 devices
1-12 of 50
Cleared Mar 06, 2026
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
K251807 · KGE
Gastroenterology & Urology · 267d
Cleared Feb 22, 2026
Single Use Distal Cover MAJ-2315 (MAJ-2315)
K253646 · FDT
Gastroenterology & Urology · 94d
Cleared Oct 24, 2025
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
K252646 · FCG
Gastroenterology & Urology · 64d
Cleared Oct 17, 2025
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series)
K250945 · KNS
Gastroenterology & Urology · 203d
Cleared Sep 19, 2025
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
K251867 · FDT
Gastroenterology & Urology · 94d
Cleared Jun 05, 2025
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
K250701 · FDT
Gastroenterology & Urology · 90d
Cleared May 27, 2025
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q
K250573 · ODD
Gastroenterology & Urology · 90d
Cleared May 01, 2025
Disposable Distal Attachment D-201 Series
K250296 · FDS
Gastroenterology & Urology · 90d
Cleared Mar 18, 2025
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
K243807 · LQR
Gastroenterology & Urology · 97d
Cleared Jun 03, 2024
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
K240617 · PKL
Gastroenterology & Urology · 90d
Cleared Dec 29, 2022
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE...
K221690 · FAJ
Gastroenterology & Urology · 202d
Cleared May 11, 2022
Evis Exera III Duodenovideoscope Olympus TJF-Q190V
K220587 · FDT
Gastroenterology & Urology · 71d

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