FDA Product Code GAG: Stapler, Surgical
FDA product code GAG covers surgical staplers for internal use during operative procedures.
These specialized instruments simultaneously cut and staple tissue layers to create anastomoses, close wounds, and resect tissue segments. They dramatically reduce the time required for complex surgical connections compared to hand-sewn techniques and are used in gastrointestinal, thoracic, and bariatric surgery.
GAG devices are Class II medical devices, regulated under 21 CFR 878.4740 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Covidien, Ethicon Endo-Surgery, LLC and Lexington Medical, Inc..
FDA 510(k) Cleared Stapler, Surgical Devices (Product Code GAG)
About Product Code GAG - Regulatory Context
510(k) Submission Activity
42 total 510(k) submissions under product code GAG since 1976, with 42 receiving FDA clearance (average review time: 86 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
Recent submissions under GAG have taken an average of 102 days to reach a decision - up from 84 days historically. Manufacturers should account for longer review timelines in current project planning.
GAG devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →