Suture, Absorbable, Synthetic, Polyglycolic Acid

What Is FDA Product Code GAM?

Suture, Absorbable, Synthetic, Polyglycolic Acid is FDA product code GAM, Class 2, 21 CFR 878.4493.

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 6 clearances under this code; the FDA took a median of 90 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 Do the Recalls Say?

The FDA has recorded 130 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Equipment maintenance (30), Process control (20) and Component change control (6).

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