# K132660: Nerve Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorporated
- Decided: Jan 10, 2014 after 137 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.
6 later devices descend from it; 3 cite it directly.
0 of 18 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 1.

## Most influential descendants
- 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) (2023), 2 descendants of its own
- K210665: Nerve Tape (2022), 1 descendant of its own
- K242113: Nerve Wrap (07-DW-001-TAB) (2025), 0 descendants of its own
- K233533: NerveTape (2024), 0 descendants of its own
- K231708: 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) (2023), 0 descendants of its own

## Indications for use
The Nerve, Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity. The device is provided sterile and intended for one-time use.

Source page: https://510kreport.com/device/K132660
Methodology: https://510kreport.com/methodology