Medical Device Manufacturer · US , Melville , NY

Olympus Medical Systems Corporation - FDA 510(k) Cleared Devices

83 submissions · 83 cleared · Since 2004

Recent clearances: EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190), HD Camera Head OLYMPUS CH-S200-08-LB, Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

83

Total

83

Cleared

0

Denied

FDA 510(k) Regulatory Record - Olympus Medical Systems Corporation Anesthesiology ✕

4 devices

1-4 of 4

Cleared Jul 29, 2025

Single Use Aspiration Needle (NA-201SX-4021)

Anesthesiology · 60d

Cleared Jun 12, 2025

Disposable Cytology Brush BC-202D/203D Series

Anesthesiology · 49d

Cleared Jun 04, 2025

Disposable Balloon Catheter B5-2C

Anesthesiology · 139d

Cleared May 30, 2025

Disposable Biopsy Forceps (FB-211D)

Anesthesiology · 60d