# K130557: Neuragen 3D

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Apr 24, 2014 after 416 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 K881854 (1988). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011168: Neurogen Nerve Guide, Integra Lifesciences Corp. (2001) Summary page 6.
- K031069: Surgisis Nerve Cuff, Cook Biotech, Inc. (2003) Summary page 6.
- K002098: Salumedica Nerve Cuff, Salumedica, LLC (2000) Summary page 1.
- K022127: Avagen Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 6.

## Most influential descendants
- K163457: NeuraGen 3D Nerve Guide Matrix (2017), 0 descendants of its own

## Indications for use
NeuraGen® 3D is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Source page: https://510kreport.com/device/K130557
Methodology: https://510kreport.com/methodology