OCU · Class II · 21 CFR 876.1500

FDA Product Code OCU: Endoscopic Storage Cover

To Protect Delicate Parts Of The Endoscope During Transport And Storage. May Also Be Used To Protect During Sterilization.

Leading manufacturers include STERIS Corporation and Ga Health Company Limited.

6
Total
6
Cleared
99d
Avg days
1994
Since

FDA 510(k) Cleared Endoscopic Storage Cover Devices (Product Code OCU)

6 devices
1–6 of 6
Cleared Mar 05, 2021
Andorate Universal Endoscope Tip Guard
K202838
Ga Health Company Limited
Gastroenterology & Urology · 161d
Cleared Jan 27, 2020
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
K191715
STERIS Corporation
Gastroenterology & Urology · 215d

About Product Code OCU - Regulatory Context

OCU devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →