Suture, Nonabsorbable, Synthetic, Polyamide

What Is FDA Product Code GAR?

Suture, Nonabsorbable, Synthetic, Polyamide is FDA product code GAR, Class 2, 21 CFR 878.5020.

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 127 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 14 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Packaging process control (4), Process control (2) and Nonconforming Material/Component (2).

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