# K201631: VersaWrap Nerve Protector

- Pathway: 510(k) (Traditional)
- Applicant: Alafair Biosciences, Inc.
- Decided: Sep 14, 2020 after 90 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: 1 generation back to K041620 (2004). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K041620: Neura Wrap Nerve Protector, Integra Lifesciences Corp. (2004) Summary page 4.

## Most influential descendants
- K232029: VersaWrap Nerve Protector (2023), 2 descendants of its own
- 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/K201631
Methodology: https://510kreport.com/methodology