FDA Product Code GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid
Under FDA product code GAM, synthetic absorbable polyglycolic acid sutures are cleared for soft tissue approximation and ligation.
These braided or monofilament sutures maintain tensile strength for 2-3 weeks then undergo hydrolytic absorption over 60-90 days, eliminating the need for suture removal. PGA sutures are used in gastrointestinal, urological, gynecological, and general surgical procedures.
GAM devices are Class II medical devices, regulated under 21 CFR 878.4493 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Ethicon, Inc..
List of Suture, Absorbable, Synthetic, Polyglycolic Acid devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Suture, Absorbable, Synthetic, Polyglycolic Acid devices (product code GAM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →