Ferrule Kit F-01-K
Ferrule Kit F-01-K is a brain-responsive electrical stimulation system (FDA Class III; FDA product code PFN, Implanted brain stimulator for epilepsy) made by Neuropace, Inc., approved under FDA PMA P100026 on 14 Nov 2013 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 00855547005175), active as of 22 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00855547005175 | Date24 Sep 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP100026 | Date14 Nov 2013 | StatusActive |
Official records
- AccessGUDID record 00855547005175
- FDA PMA database P100026
Across registries
- FDA PMA P100026 decided 14 Nov 2013 Active
- FDA GUDID UDI-DI 00855547005175 listed 24 Sep 2014 Listed
Timeline
- Approved FDA PMA P100026
- Listed FDA GUDID 00855547005175
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Ferrule Kit
- Generic name
- Brain-responsive electrical stimulation system
- Model / reference
- F-01-K
- Primary DI / UDI-DI
- 00855547005175
- PMA number
- FDA product code
- PFN
- GMDN term
- Brain-responsive electrical stimulation system
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe