510(k) · Cleared
Recalled · Class II · 2024Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ad-Tech Medical Instrument Corporation · GZL Electrode, Depth
Cleared on Apr 12, 2017 as substantially equivalent to K053358 (Ad-Tech Medical Instrument Corp, 2006) and 5 other predicates after a 133-day review. Its family tree reaches back 6 generations to 1981. 5 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 12, 2017
- Review
- 133 days
- Class
- Class II
- Product code
- GZL
- Recalls
- 5
- Predicates
- 6
Its longest line of descent runs back 6 generations to K811452 (1981). 16 ancestors in all, the oldest K802151 (1980). 5 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 5 generations backK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
- 4 generations backK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
- 3 generations backK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- 2 generations backK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- 1 generation backK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- This deviceK163355 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth…Ad-Tech Medical Instrument Corporation · 2017
- Descendant · cites it directly · 1 of its ownK201678 iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK250363 Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth…Beijing Sinovation Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK223269 Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK222706 iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK202087 DIXI Medical Microdeep Micro-Macro Depth ElectrodesDixi Medical · 2021
Most influential descendants
Showing 5 of 5 · See all- K201678iCE-SG Subcutaneous Electrode ArraysIce Neurosystems, Inc. · 2021 · cites it directly1descendant
- K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…Beijing Sinovation Medical Technology Co., Ltd. · 2025 · cites it directly0descendants
- K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation · 2023 · cites it directly0descendants
- K222706iCE-SG2 Subcutaneous Electrode KitIce Neurosystems, Inc. · 2022 · 2 generations on0descendants
- K202087DIXI Medical Microdeep Micro-Macro Depth ElectrodesDixi Medical · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −5 | K961858 | Cosgrove Depth Electrode Kit (Cdek) | Radionics, Inc. | 1996 | — |
| −4 | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | 3 |
| −3 | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| −2 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| −1 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| 0 (this device) | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes… | Ad-Tech Medical Instrument Corporation | 2017 | — |
| +1 | K201678 | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | 2021 | — |
| +1 | K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode… | Beijing Sinovation Medical Technology Co., Ltd. | 2025 | — |
| +1 | K223269 | Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2023 | — |
| +2 | K222706 | iCE-SG2 Subcutaneous Electrode Kit | Ice Neurosystems, Inc. | 2022 | — |
| +1 | K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes | Dixi Medical | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2005 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesSummary page 4…21 CFR 882.1330 Product Code: GZL Class II Predicate Devices: K053358 Depth Electrode (Primary Predicate) Ad-Tech Medical Instrument Corporation… | 2006 |
| * | K964644 | AD-Tech's Depth ElectrodeSummary page 4…edicate Devices: K053358 Depth Electrode (Primary Predicate) Ad-Tech Medical Instrument Corporation K964644 Depth Electrode Ad-Tech Medical Instrument Corporation K990788 Fo… | 1997 |
| * | K990788 | AD-Tech's Foramen Ovale ElectrodeSummary page 4…orporation K964644 Depth Electrode Ad-Tech Medical Instrument Corporation K990788 Foramen Ovale Electrode Ad-Tech Medical Instrument Corporation K0… | 1999 |
| * | K041604 | Macro-Micro Depth ElectrodeSummary page 4…on K990788 Foramen Ovale Electrode Ad-Tech Medical Instrument Corporation K041604 Macro-Micro Depth Electrode Ad-Tech Medical Instrument Corporation… | 2004 |
| * | K802151 | PMT Depthalon Depth Corticography ElecSummary page 4…K041604 Macro-Micro Depth Electrode Ad-Tech Medical Instrument Corporation K802151 and K151790 PMT Depthalon Electrodes PMT Corporation Reference Device: K944061 Cuev… | 1980 |
| * | K151790 | PMT Platinum Depthalon Depth ElectrodeSummary page 4…K041604 Macro-Micro Depth Electrode Ad-Tech Medical Instrument Corporation K802151 and K151790 PMT Depthalon Electrodes PMT Corporation Reference Device: K944061 Cueva Cranial Ne… | 2016 |
| † | K944061 | Cueva Cranial Nerve Electrode | 1995 |
What descends from it? (5)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2024 | Class II | Z-0221-2025 | Employee error | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style… |
| Sep 19, 2024 | Class II | Z-0219-2025 | Employee error | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style… |
| Sep 19, 2024 | Class II | Z-0220-2025 | Employee error | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style… |
| Jun 18, 2019 | Class II | Z-2407-2019 | Employee error | Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use. |
| Apr 16, 2019 | Class II | Z-2396-2019 | Labeling Change Control | An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K201678 (Ice Neurosystems, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K053358.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163355: Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163355
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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