# K242113: Nerve Wrap (07-DW-001-TAB)

- Pathway: 510(k) (Traditional)
- Applicant: Biocircuit Technologies, Inc.
- Decided: Apr 2, 2025 after 257 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: 6 generations back to K921895 (1992). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223640: Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48), Axogen Corporation (2023) Summary page 5.

## Indications for use
Nerve Wrap is indicated for the management of peripheral nerve injuries where there is no gap.

Source page: https://510kreport.com/device/K242113
Methodology: https://510kreport.com/methodology