510(k) · Cleared
ClearedGuideline System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axon Instruments, Inc. · GZL Electrode, Depth
Cleared on Aug 18, 1997 after a 157-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Aug 18, 1997
- Review
- 157 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK970943 Guideline SystemAxon Instruments, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK993622 Neurotrek Physiological Navigation System for NeurosurgeryAlpha Omega, Ltd. · 2000
- Descendant · cites it directly · 3 of its ownK071364 Microtargeting Guideline 4000FHC, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK183123 microTargeting Guideline 4000 5.0 SystemFHC, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK250094 Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox…Neuralynx, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK140680 Leadpoint Focus Workststion, Leadpoint Focus Notebook SystemAlpine Biomed Aps · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K993622Neurotrek Physiological Navigation System for NeurosurgeryAlpha Omega, Ltd. · 2000 · cites it directly4descendants
- K071364Microtargeting Guideline 4000FHC, Inc. · 2007 · cites it directly3descendants
- K183123microTargeting Guideline 4000 5.0 SystemFHC, Inc. · 2018 · 2 generations on1descendant
- K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc. · 2025 · 3 generations on0descendants
- K140680Leadpoint Focus Workststion, Leadpoint Focus Notebook SystemAlpine Biomed Aps · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970943 | Guideline System | Axon Instruments, Inc. | 1997 | — |
| +1 | K993622 | Neurotrek Physiological Navigation System for Neurosurgery | Alpha Omega, Ltd. | 2000 | — |
| +1 | K071364 | Microtargeting Guideline 4000 | FHC, Inc. | 2007 | 1 |
| +2 | K183123 | microTargeting Guideline 4000 5.0 System | FHC, Inc. | 2018 | 1 |
| +3 | K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof)… | Neuralynx, Inc. | 2025 | — |
| +2 | K140680 | Leadpoint Focus Workststion, Leadpoint Focus Notebook System | Alpine Biomed Aps | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZL device
- #1 K253970 Wovyn Depth Electrodescore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993622 (Alpha Omega, Ltd., 2000) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZL
206in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZL
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZL
12in 2025
MAUDE reports naming product code GZL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 166 | 0 | 0 |
| 2008 | 0 | — | 3 | 8 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 25 |
| 2014 | 1 | — | 1 | 7 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 222 | 0 | 3 |
| 2018 | 3 | 58 | 0 | 2 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 24 |
| 2021 | 3 | 262 | 9 | 13 |
| 2022 | 3 | 90 | 0 | 10 |
| 2023 | 3 | 206 | 0 | 30 |
| 2024 | 0 | — | 3 | 16 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
To record from and stimulate brain motor and sensory neurons to aid in tiie placement of depth electrodes.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970943 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970943: Guideline System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970943
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026