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..