FDA Product Code GEH: Unit, Cryosurgical, Accessories

Under FDA product code GEH, cryosurgical units and their accessories are cleared for tissue destruction through the controlled application of extreme cold.

These devices use liquid nitrogen, argon, or nitrous oxide to rapidly freeze and destroy targeted tissue through ice crystal formation and vascular disruption. Cryosurgery is used in dermatology, gynecology, urology, and interventional oncology for the ablation of tumors and lesions.

GEH devices are Class II medical devices, regulated under 21 CFR 878.4350 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Galil Medical , Ltd., Endocare, Inc. and CSA Medical, Inc..