Transformer, Endoscope

How Is GCW Classified?

Transformer, Endoscope is FDA product code GCW, Class 2, 21 CFR 876.1500.

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 Do the Recalls Say?

The FDA has recorded 6 recalls under this product code since 2015. None was by a company in China. The root cause the FDA records most often is Device Design (4).

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