510(k) · Cleared
ClearedWovyn Depth Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensomedical Labs, Ltd. · GZL Electrode, Depth
Cleared on Apr 17, 2026 as substantially equivalent to K213170 (Sensomedical Labs, Ltd., 2023) and 1 other predicate after a 127-day review. Its family tree reaches back 8 generations to 1981.
- Decided
- Apr 17, 2026
- Review
- 127 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K811452 (1981). 20 ancestors in all, the oldest K802152 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- 7 generations backK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
- 6 generations backK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
- 5 generations backK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- 4 generations backK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- 3 generations backK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- 2 generations backK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · Recalled
- 1 generation backK213170 SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023
- This deviceK253970 Wovyn Depth ElectrodeSensomedical Labs, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| −7 | K961858 | Cosgrove Depth Electrode Kit (Cdek) | Radionics, Inc. | 1996 | — |
| −6 | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | 3 |
| −5 | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| −4 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| −3 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| −2 | K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017 | 9 |
| −1 | K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | 2023 | — |
| 0 (this device) | K253970 | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | 2026 | — |
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 | 3 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2016 | 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 K250363 Depth Electrode (RSDE-08); Depth Electrode…score 12.7 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K213170 | SENSOSEEG Depth ElectrodesSummary page 5…I — 21 CFR 882.1330; Product Code: GZL Review Panel: Neurological and Physical Medicine Primary Predicate: SENSO SEEG Depth Electrode — 510(k) K213170 (Sensomedical Labs, Ltd.) Secondary Predicate: PMT Depthalon Electrode — 510(k) K151790 (P… | 2023 |
| * | K151790 | PMT Platinum Depthalon Depth ElectrodeSummary page 5…SENSO SEEG Depth Electrode — 510(k) K213170 (Sensomedical Labs, Ltd.) Secondary Predicate: PMT Depthalon Electrode — 510(k) K151790 (PMT Medical) Date of Summary: March 18, 2026 2. Device Description The Wovyn Depth Electrode is a single-use,… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 45 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 20 ancestors have a recall of any class.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Sensomedical Wovyn 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253970 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253970: Wovyn Depth Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253970
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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