# K071697: Neuronav System and Neuronav Drive

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Omega, Ltd.
- Decided: Dec 3, 2007 after 166 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K172042: NeuroNav System, NeuroSmart System (2018), 2 descendants of its own
- K220553: Neuro Omega System, NeuroSmart System (2022), 1 descendant of its own
- K250601: Neuro Omega System; NeuroSmart System (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K071697
Methodology: https://510kreport.com/methodology