FDA Product Code GXD: Generator, Lesion, Radiofrequency
Leading manufacturers include Abbott Medical, Rf Innovations, Inc. and Neuroone Medical Technologies Corp..
FDA 510(k) Cleared Generator, Lesion, Radiofrequency Devices (Product Code GXD)
About Product Code GXD - Regulatory Context
510(k) Submission Activity
37 total 510(k) submissions under product code GXD since 1991, with 37 receiving FDA clearance (average review time: 200 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 GXD have taken an average of 135 days to reach a decision - down from 206 days historically, suggesting improved FDA processing for this classification.
GXD devices are reviewed by the Neurology panel. Browse all Neurology devices →