FDA Product Code GXI: Probe, Radiofrequency Lesion
Under FDA product code GXI, radiofrequency lesion probes are cleared for creating precise thermal lesions in neural tissue for pain management and movement disorder treatment.
These electrodes deliver controlled radiofrequency energy to create a coagulative lesion at a specific neural target — interrupting pain pathways or abnormal motor circuits. They are used in trigeminal neuralgia, cancer pain, and movement disorder surgery.
GXI devices are Class II medical devices, regulated under 21 CFR 882.4725 and reviewed by the FDA Neurology panel.
Leading manufacturers include Abbott Medical, Shanghai Samedical & Plastic Instruments Co., Ltd. and Stryker Instruments.
FDA 510(k) Cleared Probe, Radiofrequency Lesion Devices (Product Code GXI)
About Product Code GXI - Regulatory Context
510(k) Submission Activity
66 total 510(k) submissions under product code GXI since 1980, with 66 receiving FDA clearance (average review time: 132 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GXI have taken an average of 185 days to reach a decision - up from 126 days historically. Manufacturers should account for longer review timelines in current project planning.
GXI devices are reviewed by the Neurology panel. Browse all Neurology devices →