# K232029: VersaWrap Nerve Protector

- Pathway: 510(k) (Traditional)
- Applicant: Alafair Biosciences, Inc.
- Decided: Nov 2, 2023 after 118 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: 2 generations back to K041620 (2004). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201631: VersaWrap Nerve Protector, Alafair Biosciences, Inc. (2020) Summary page 5.

## Most influential descendants
- K251505: VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (2025), 0 descendants of its own
- K251175: VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) (2025), 0 descendants of its own

## 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/K232029
Methodology: https://510kreport.com/methodology