Medical Device Manufacturer · JP , Hachiochi-Shi

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

104 submissions · 104 cleared · Since 2012

Recent clearances: 4K Camera Head OLYMPUS CH-S700-08-LB, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS), Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)

View 104 510(k) Devices ↓ Official Website

104

Total

104

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Mar 31, 2025

Disposable Grasping Forceps FG-52D/FG-54D

Anesthesiology · 61d

Cleared Sep 22, 2021

Single Use Guide Sheath Kit-401, K-402

Anesthesiology · 30d

Cleared Mar 06, 2020

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

Anesthesiology · 210d

Cleared Dec 10, 2019

Single Use Aspiration Needle

Anesthesiology · 307d

Cleared Aug 02, 2019

Single Use Cytology Brush BC-205D

Anesthesiology · 172d

Cleared Nov 30, 2018

Single Use Hot Biopsy Forceps FD-231

Anesthesiology · 382d