Endoscopic Storage Cover

What Is It?

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

How Is OCU Classified?

Endoscopic Storage Cover is FDA product code OCU, Class 2, 21 CFR 876.1500.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 161 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2026. None was by a company in China. The root cause the FDA records most often is No Marketing Application (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.