# K162741: AxoGuard Nerve Connector

- Pathway: 510(k) (Special)
- Applicant: Cook Biotech Incorporated
- Decided: Oct 31, 2016 after 31 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: 4 generations back to K921895 (1992). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031069: Surgisis Nerve Cuff, Cook Biotech, Inc. (2003) Summary page 4.

## Most influential descendants
- K210665: Nerve Tape (2022), 1 descendant of its own
- K233533: NerveTape (2024), 0 descendants of its own

## Indications for use
The Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K162741
Methodology: https://510kreport.com/methodology