K251175
- 510(k) number
- K251175
- Device name
- VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)
- Applicant
- Alafair Biosciences TX · US
- Product code
- JXI — Cuff, Nerve
- Decision date
- 2025-07-17
- Date received
- 2025-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K251175.pdf
Official FDA record: K251175
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.