# K002098: Salumedica Nerve Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Salumedica, LLC
- Decided: Nov 24, 2000 after 136 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
No predicates in its family tree.
40 later devices descend from it; 5 cite it directly.
0 of 41 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) FastubeTM Nerve Cuff: named in the summary without a submission number
- (no number) silicone nerve cuffs: 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

## Indications for use
Repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity

Source page: https://510kreport.com/device/K002098
Methodology: https://510kreport.com/methodology