Instrument, Biopsy

What Is FDA Product Code KNW?

Instrument, Biopsy is FDA product code KNW, Class 2, 21 CFR 876.1075.

How Does It Reach the US Market?

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 13 clearances under this code; the FDA took a median of 171 days from receipt to decision on them.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 106 recalls under this product code since 2003. None was by a company in China. 4 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (16), Package design/selection (14) and Packaging process control (10). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.