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 Livsmed, Inc., BTL Industries, Inc. and ShenB Co., Ltd..