K251505
- 510(k) number
- K251505
- Device name
- VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
- Applicant
- Alafair Biosciences TX · US
- Product code
- JXI — Cuff, Nerve
- Decision date
- 2025-07-22
- Date received
- 2025-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K251505.pdf
Official FDA record: K251505
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.