FDA Product Code GEI: Electrosurgical, Cutting & Coagulation & Accessories
FDA product code GEI covers electrosurgical cutting and coagulation devices and their accessories.
These systems use high-frequency electrical current to cut tissue and control bleeding simultaneously during surgical procedures. They are among the most widely used tools in operating rooms across all surgical specialties.
GEI devices are Class II medical devices, regulated under 21 CFR 878.4400 and reviewed by the FDA General & Plastic Surgery panel. Reusable devices require validated reprocessing instructions.
Leading manufacturers include BTL Industries, Inc., Livsmed, Inc. and Erbe Elektromedizin GmbH.
FDA 510(k) Cleared Electrosurgical, Cutting & Coagulation & Accessories Devices (Product Code GEI)
About Product Code GEI - Regulatory Context
510(k) Submission Activity
2295 total 510(k) submissions under product code GEI since 1976, with 2295 receiving FDA clearance (average review time: 110 days).
Submission volume has remained relatively stable over the observed period, with 104 submissions in the last 24 months.
FDA Review Time
Recent submissions under GEI have taken an average of 151 days to reach a decision - up from 109 days historically. Manufacturers should account for longer review timelines in current project planning.
GEI devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →