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., United States Surgical, A Division of Tyco Healthc and Surgical Specialties Corp.