GWG · Class II · 21 CFR 882.1480

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 Stryker, Carl Zeiss Meditec, AG and Integra LifeSciences Corporation.

3
Total
3
Cleared
66d
Avg days
2021
Since

List of Endoscope, Neurological devices cleared through 510(k)

3 devices
1–3 of 3

How to use this database

This page lists all FDA 510(k) submissions for Endoscope, Neurological devices (product code GWG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Neurology FDA review panel. Browse all Neurology devices →