FDA 510(k) Neurology Devices
About Neurology Devices
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
FDA 510(k) Cleared Neurology Devices
This page lists all 133 medical devices in the Neurology specialty that have been submitted to the FDA through the 510(k) premarket notification process. EEG systems, neurostimulators, robotic surgical navigation and neuromonitoring.
- 133 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 165 days.
- Records available from 2021 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 133 medical devices in the Neurology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 133 were cleared as substantially equivalent to a predicate device. Average FDA review time: 165 days. Records from 2021 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to neurology
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific neurology device? Search by device name, K-number or manufacturer.
Search all Neurology 510(k) devices