# K031069: Surgisis Nerve Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: May 15, 2003 after 41 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: 3 generations back to K921895 (1992). 10 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K011168: Neurogen Nerve Guide, Integra Lifesciences Corp. (2001)
- K002098: Salumedica Nerve Cuff, Salumedica, LLC (2000) Summary page 1.
- K012814: Collagen Nerve Cuff, Collagen Matrix, Inc. (2001)

## Most influential descendants
- K132660: Nerve Cuff (2014), 6 descendants of its own
- 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
- K162741: AxoGuard Nerve Connector (2016), 2 descendants of its own
- K210665: Nerve Tape (2022), 1 descendant of its own
- K130557: Neuragen 3D (2014), 1 descendant of its own

## Indications for use
The SURGISIS 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/K031069
Methodology: https://510kreport.com/methodology