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 Baylis Medical Co., Inc., Diros Technology, Inc. and Smith & Nephew, Inc..