# K011168: Neurogen Nerve Guide

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Jun 22, 2001 after 66 days
- Product code: JXI (Cuff, Nerve)
- Device class: 2
- Regulation: 21 CFR 882.5275
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 9 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Salumedica™ Nerve Cuff: named in the summary without a submission number
- (no number) NeuroTube®: named in the summary without a submission number
- (no number) Fastube™ Nerve Cuff: named in the summary without a submission number

## Most influential descendants
- K012814: Collagen Nerve Cuff (2001), 37 descendants of its own
- K060952: Collagen Nerve Wrap (2006), 22 descendants of its own
- K080452: Collagen Tendon Wrap (2008), 15 descendants of its own
- K112423: Collagen Tendon Sheet (2011), 14 descendants of its own
- K031069: Surgisis Nerve Cuff (2003), 10 descendants of its own

## Recalls of this device
- Feb 7, 2020 · Class III · Z-1470-2020: Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
- Mar 28, 2013 · Class II · Z-1287-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

## Indications for use
NeuroGen™ Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Source page: https://510kreport.com/device/K011168
Methodology: https://510kreport.com/methodology