# K991522: Microtargeting Electrode

- Pathway: 510(k) (Traditional)
- Applicant: FHC, Inc.
- Decided: Aug 4, 2000 after 459 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K811452 (1981). 5 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991077: Microelectroencephalography Professional System 5000 (Eeg Pro System 5000), Microrecording Systems Consultants, LLC (1999). Cleared while this submission was under review Summary page 2.
- K981015: Pali-Trode, Preferred Instruments (1998) Summary page 2.
- K961858: Cosgrove Depth Electrode Kit (Cdek), Radionics, Inc. (1996) Summary page 2.

## Most influential descendants
- K033173: Micro Targeting Electrode (2004), 16 descendants of its own
- K041604: Macro-Micro Depth Electrode (2004), 12 descendants of its own
- K053358: Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes (2006), 11 descendants of its own
- K170959: DIXI Medical Microdeep Depth Electrode (2017), 5 descendants of its own
- K163355: Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes (2017), 5 descendants of its own

## Recalls of this device
- Oct 20, 2008 · Not classified · Z-0499-2009: Mislabeled: May contain an electrode longer than labeled size
- Oct 20, 2008 · Not classified · Z-0497-2009: Mislabeled: May contain an electrode longer than labeled size
- Oct 20, 2008 · Not classified · Z-0498-2009: Mislabeled: May contain an electrode longer than labeled size

## Indications for use
The microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal activity in the brain.

Source page: https://510kreport.com/device/K991522
Methodology: https://510kreport.com/methodology