# K032115: Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

- Pathway: 510(k) (Traditional)
- Applicant: Polyganics B.V.,
- Decided: Oct 10, 2003 after 93 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: 1 generation back to K983007 (1999). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983007: Neurotube, Neuroregen, LLC (1999) Summary page 1.
- K011168: Neurogen Nerve Guide, Integra Lifesciences Corp. (2001)

## Most influential descendants
- K112267: Neurolac (R) Nerve Guide (2011), 3 descendants of its own
- K050573: Neurolac Nerve Guide (2005), 2 descendants of its own
- K260245: SILKBridge (2026), 0 descendants of its own
- K230794: Rebuilder Nerve Guidance Conduit (2024), 0 descendants of its own
- K152684: Nerve Capping Device (2016), 0 descendants of its own

## Indications for use
The Neurolac nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Source page: https://510kreport.com/device/K032115
Methodology: https://510kreport.com/methodology