Medical Device Manufacturer · US , Melville , NY

Olympus Winter & Ibe GmbH - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1997

Recent clearances: OES ELITE Cystoscope and Accessories, Bipolar applicator CelonProBreath (WB990310), Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)

43

Total

43

Cleared

0

Denied

FDA 510(k) Regulatory Record - Olympus Winter & Ibe GmbH Obstetrics & Gynecology ✕

4 devices

1-4 of 4

Cleared Dec 22, 2021

Sheath, Stopcock Accessory

Obstetrics & Gynecology · 84d

Cleared Aug 03, 2021

Resection Electrodes with HF cable

Obstetrics & Gynecology · 152d

Cleared Aug 29, 2019

ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)

Obstetrics & Gynecology · 160d

Cleared Nov 21, 2014

Obstetrics & Gynecology · 74d