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 Cryoconcepts LP, Cryosurgery, Inc. and Recensmedical, Inc..
FDA 510(k) Cleared Unit, Cryosurgical, Accessories Devices (Product Code GEH)
About Product Code GEH - Regulatory Context
510(k) Submission Activity
261 total 510(k) submissions under product code GEH since 1976, with 261 receiving FDA clearance (average review time: 108 days).
Submission volume has increased in recent years - 23 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for GEH submissions have been consistent, averaging 116 days recently vs 107 days historically.
GEH devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →