# K152684: Nerve Capping Device

- Pathway: 510(k) (Traditional)
- Applicant: Polyganics Innovations BV
- Decided: Jan 13, 2016 after 117 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 K983007 (1999). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050573: Neurolac Nerve Guide, Polyganics B.V., (2005) Summary page 4.
- K112267: Neurolac (R) Nerve Guide, Polyganics B.V., (2011) Summary page 4.
- K131541: Flexible Cooagen Nerve Cuff, Collagen Matrix, Inc. (2014) Summary page 4.

## Indications for use
The Nerve Capping Device is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma.

Source page: https://510kreport.com/device/K152684
Methodology: https://510kreport.com/methodology