FDA 510(k) Neurology Devices

FDA 510(k) Neurology Devices - Regulatory Overview

FDA 510(k) neurology devices cover diagnostic and therapeutic equipment for the nervous system. The FDA review panel code is NE.

Common categories include:

• EEG and neurophysiology systems - electroencephalographs, EMG, nerve conduction
• Neurostimulators - transcranial magnetic stimulation (TMS), vagus nerve stimulation
• Surgical navigation systems - image-guided neurosurgery platforms
• Intracranial pressure monitors - ICP sensors and drainage systems
• Neuroendoscopes - rigid and flexible scopes for minimally invasive neurosurgery