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

Olympus Medical Systems Corp. has 100 FDA 510(k) cleared medical devices. Based in Hachiochi-Shi, JP.

Latest FDA clearance: Mar 2026. Active since 2012. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Olympus Medical Systems Corp. Filter by specialty or product code using the sidebar.

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

100 devices
1-12 of 100
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 Nov 12, 2025
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)
K251336 · OWN
General & Plastic Surgery · 196d
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 23, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190)
K250862 · EOQ
Ear, Nose, Throat · 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 31, 2025
Disposable Grasping Forceps FG-52D/FG-54D
K250263 · KTI
Anesthesiology · 61d
Cleared Mar 18, 2025
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
K243807 · LQR
Gastroenterology & Urology · 97d

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