Anoscope and Accessories

What Is It?

To examine and perform procedures within the anus and rectum.

How Is FER Classified?

Anoscope And Accessories is FDA product code FER, 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 304 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2018. None was by a company in China. The root cause the FDA records most often is Device Design (1).

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