# K251175: VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)

- Pathway: 510(k) (Traditional)
- Applicant: Alafair Biosciences
- Decided: Jul 17, 2025 after 92 days
- Product code: JXI (Cuff, Nerve)
- Device class: 2
- Regulation: 21 CFR 882.5275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K041620 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232029: VersaWrap Nerve Protector, Alafair Biosciences, Inc. (2023) Summary page 5.

## Indications for use
VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Source page: https://510kreport.com/device/K251175
Methodology: https://510kreport.com/methodology