OCU

Endoscopic Storage Cover

Product code

OCU

Device name

Endoscopic Storage Cover

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification definition

To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.

Definition text from the FDA device classification database (U.S. federal government work, public domain).