Device, Cystometric, Hydraulic

What Is FDA Product Code FEN?

Device, Cystometric, Hydraulic is FDA product code FEN, Class 2, 21 CFR 876.1620.

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

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2006. None was by a company in China. The root cause the FDA records most often is Nonconforming Material/Component (2).

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