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., Peters Surgical and Internacional Farmac?utica S.A DE C.V.
FDA 510(k) Cleared Suture, Absorbable, Synthetic, Polyglycolic Acid Devices (Product Code GAM)
About Product Code GAM - Regulatory Context
510(k) Submission Activity
147 total 510(k) submissions under product code GAM since 1991, with 147 receiving FDA clearance (average review time: 115 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GAM have taken an average of 159 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.
GAM devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →