# K041620: Neura Wrap Nerve Protector

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Jul 16, 2004 after 30 days
- Product code: JXI (Cuff, Nerve)
- Device class: 2
- Regulation: 21 CFR 882.5275
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
52 later devices descend from it; 6 cite it directly.
0 of 53 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) NeuraGen Nerve Guide: named in the summary without a submission number
- (no number) Fastube Nerve Cuff: named in the summary without a submission number

## Most influential descendants
- K053655: Tendon Wrap Tendon Protector (2006), 39 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
- K061473: Surgi-Wrap Mast Bioresorbable Sheet (2006), 13 descendants of its own

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1286-2013: 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
NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Source page: https://510kreport.com/device/K041620
Methodology: https://510kreport.com/methodology