# K082404: Navigation Probes

- Pathway: 510(k) (Traditional)
- Applicant: We Sense, Ltd.
- Decided: Feb 25, 2009 after 188 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
Longest line of descent: 4 generations back to K811452 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033173: Micro Targeting Electrode, FHC, Inc. (2004) Summary page 2.

## Indications for use
We Sense NavigationProbes electrodes are hitended to be used in operation room (iring neurosurgelr for temporary (less than two hours) recording and stimulation of defined small area i tile brail, and for recordhig electrical signals from target brain cells. These elech'odes can be used only by professional staff' and not sell over the cotuiter

Source page: https://510kreport.com/device/K082404
Methodology: https://510kreport.com/methodology