# K970943: Guideline System

- Pathway: 510(k) (Traditional)
- Applicant: Axon Instruments, Inc.
- Decided: Aug 18, 1997 after 157 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.
6 later devices descend from it; 3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993622: Neurotrek Physiological Navigation System for Neurosurgery (2000), 4 descendants of its own
- K071364: Microtargeting Guideline 4000 (2007), 3 descendants of its own
- 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

## Indications for use
To record from and stimulate brain motor and sensory neurons to aid in tiie placement of depth electrodes.

Source page: https://510kreport.com/device/K970943
Methodology: https://510kreport.com/methodology