FDA 510(k) neurology devices cover diagnostic and therapeutic equipment for the nervous system. The FDA review panel code is NE.
Common categories include:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 153d |
| All-time average (cleared) | 148d |
| Not Substantially Equivalent (denied) | 419d |
FDA review times for Neurology submissions have remained consistent, averaging 153 days for cleared devices. Denied submissions averaged 419 days before receiving a Not Substantially Equivalent determination.
This page lists all 6291 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.
This page lists 6291 medical devices in the Neurology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 6236 were cleared as substantially equivalent to a predicate device. Average FDA review time: 148 days. Records from 1976 to the present.
You can use this list to:
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.
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