Suture, Nonabsorbable, Synthetic, Polypropylene

What Is FDA Product Code GAW?

Suture, Nonabsorbable, Synthetic, Polypropylene is FDA product code GAW, Class 2, 21 CFR 878.5010.

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. Chinese applicants hold 1 clearance under this code; the FDA took 181 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 28 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Package design/selection (19), Process control (4) and Packaging process control (2).

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