Motor, Surgical Instrument, Pneumatic Powered

How Is GET Classified?

Motor, Surgical Instrument, Pneumatic Powered is FDA product code GET, Class 1, 21 CFR 878.4820.

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 54 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Process control (47) and Device Design (1).

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