FDA Product Code GWG: Endoscope, Neurological
Direct visualization of the brain and spinal canal enables minimally invasive neurosurgical procedures. FDA product code GWG covers neurological endoscopes and their accessories.
These rigid or flexible endoscopes provide direct optical access to the ventricular system, spinal canal, and intracranial spaces for the treatment of hydrocephalus, intraventricular tumors, and syringomyelia through minimally invasive approaches.
GWG devices are Class II medical devices, regulated under 21 CFR 882.1480 and reviewed by the FDA Neurology panel.
Leading manufacturers include Integra LifeSciences Corporation, Stryker and Clarus Medical, LLC.
FDA 510(k) Cleared Endoscope, Neurological Devices (Product Code GWG)
About Product Code GWG - Regulatory Context
510(k) Submission Activity
91 total 510(k) submissions under product code GWG since 1992, with 91 receiving FDA clearance (average review time: 157 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under GWG have taken an average of 183 days to reach a decision - up from 156 days historically. Manufacturers should account for longer review timelines in current project planning.
GWG devices are reviewed by the Neurology panel. Browse all Neurology devices →