Medical Device Manufacturer · US , Melville , NY

Olympus Optical Co., Ltd. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2000

Official Website

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Olympus Optical Co., Ltd. Gastroenterology & Urology ✕

6 devices

1-6 of 6

Cleared Jul 16, 2003

OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE

Gastroenterology & Urology · 9d

Cleared Dec 20, 2002

XTJF-160AF DUODENOVIDEOSCOPE

Gastroenterology & Urology · 14d

Cleared Jul 05, 2002

DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A

Gastroenterology & Urology · 81d

Cleared Aug 10, 2001

OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1

Gastroenterology & Urology · 88d

Cleared Jan 30, 2001

LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY...

Gastroenterology & Urology · 190d

Cleared Sep 08, 2000

OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE

Gastroenterology & Urology · 88d