K232029
- 510(k) number
- K232029
- Device name
- VersaWrap Nerve Protector
- Applicant
- Alafair Biosciences, Inc. TX · US
- Product code
- JXI — Cuff, Nerve
- Decision date
- 2023-11-02
- Date received
- 2023-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K232029.pdf
Official FDA record: K232029
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.