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 Neuro Navigational Corp., KARL STORZ Endoscopy-America, Inc. and Clarus Medical Systems, Inc..