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 Varian Medical Systems, Inc., Pentax of America, Inc. and STERIS Corporation.
List of Unit, Cryosurgical, Accessories devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Unit, Cryosurgical, Accessories devices (product code GEH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →