# K071364: Microtargeting Guideline 4000

- Pathway: 510(k) (Traditional)
- Applicant: FHC, Inc.
- Decided: Jul 25, 2007 after 70 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970943 (1997). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970943: Guideline System, Axon Instruments, Inc. (1997) Summary page 1.
- K993622: Neurotrek Physiological Navigation System for Neurosurgery, Alpha Omega, Ltd. (2000) Summary page 1.

## Most influential descendants
- K183123: microTargeting Guideline 4000 5.0 System (2018), 1 descendant of its own
- K250094: Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (2025), 0 descendants of its own
- K140680: Leadpoint Focus Workststion, Leadpoint Focus Notebook System (2014), 0 descendants of its own

## Recalls of this device
- Dec 28, 2009 · Not classified · Z-1143-2010: The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if used to identify the implantation target for the DBS lead, the implant may be placed in the 

## Indications for use
The microTargeting® Guideline 4000 system is intended to assist in functional neurosurgical procedures where recording from and stimulation of brain motor and sensory neurons will aid in the placement of depth electrodes.

Source page: https://510kreport.com/device/K071364
Methodology: https://510kreport.com/methodology