FDA Product Code GXH: Device, Surgical, Cryogenic
FDA product code GXH covers surgical cryogenic devices used for neurosurgical ablation.
These probes deliver extreme cold — typically through liquid nitrogen or argon-based systems — to ablate neural tissue for the treatment of movement disorders, chronic pain, and brain tumors. Cryosurgery creates well-defined lesions with sharp margins in brain tissue.
GXH devices are Class II medical devices, regulated under 21 CFR 882.4250 and reviewed by the FDA Neurology panel.
Leading manufacturers include AtriCure, Inc..
List of Device, Surgical, Cryogenic devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Device, Surgical, Cryogenic devices (product code GXH). 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 Neurology FDA review panel. Browse all Neurology devices →