Tray, Biopsy, Without Biopsy Instruments

How Is FCH Classified?

Tray, Biopsy, Without Biopsy Instruments is FDA product code FCH, Class 1, 21 CFR 876.4730.

How Does It Reach the US Market?

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 14 recalls under this product code since 2012. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (4), Material/Component Contamination (2) and Device Design (2).

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