# K152967: Nerbridge

- Pathway: 510(k) (Traditional)
- Applicant: Toyobo Co., Ltd.
- Decided: Jun 22, 2016 after 258 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 K850785 (1985). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103081: Covaortho-Nerve Resorbable Collagen Membrane, Biom'Up Sas (2012) Summary page 4.
- K983007: Neurotube, Neuroregen, LLC (1999) Summary page 4.

## Most influential descendants
- K190246: NeuroShield (2019), 0 descendants of its own

## Indications for use
Nerbridge™ is intended for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.

Source page: https://510kreport.com/device/K152967
Methodology: https://510kreport.com/methodology