# K233322: Mochida Nerve Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Mochida Pharmaceutical Co., Ltd.
- Decided: Jun 21, 2024 after 266 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)
- K060952: Collagen Nerve Wrap, Collagen Matrix, Inc. (2006) Summary page 5.
- K012814: Collagen Nerve Cuff, Collagen Matrix, Inc. (2001) Summary page 5.

## Indications for use
Mochida Nerve Cuff is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Source page: https://510kreport.com/device/K233322
Methodology: https://510kreport.com/methodology