# K100382: Salutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331

- Pathway: 510(k) (Traditional)
- Applicant: Salumedica, LLC
- Decided: Aug 5, 2010 after 170 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 K850785 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002098: Salumedica Nerve Cuff, Salumedica, LLC (2000) Summary page 1.
- K041620: Neura Wrap Nerve Protector, Integra Lifesciences Corp. (2004) Summary page 1.
- K060952: Collagen Nerve Wrap, Collagen Matrix, Inc. (2006) Summary page 1.

## Indications for use
The SaluTunnel™ 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/K100382
Methodology: https://510kreport.com/methodology