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. and Pacira Biosciences, Inc..
FDA 510(k) Cleared Device, Surgical, Cryogenic Devices (Product Code GXH)
About Product Code GXH - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code GXH since 1978, with 23 receiving FDA clearance (average review time: 93 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GXH have taken an average of 39 days to reach a decision - down from 101 days historically, suggesting improved FDA processing for this classification.
GXH devices are reviewed by the Neurology panel. Browse all Neurology devices →