FDA product code GZL: Electrode, Depth
GZL is the FDA product code for electrode, depth. It is a Class II device, regulated under 21 CFR 882.1330 and reviewed by the Neurology panel. FDA has cleared 58 510(k) submissions under GZL, 9 in the last five years, from 28 different applicants. The average 510(k) review took 175 days (median 170); 138 days on average over the last three years. FDA has posted 24 recalls for GZL devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Depth |
| Device class | Class II |
| Regulation | 21 CFR 882.1330 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GZL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 216 |
| 2018 | 3 | 110 |
| 2020 | 1 | 188 |
| 2021 | 3 | 287 |
| 2022 | 3 | 121 |
| 2023 | 3 | 326 |
| 2025 | 2 | 149 |
| 2026 | 1 | 127 |
Compare with all 510(k) review times · Search every GZL clearance
Top GZL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alpha Omega Engineering , Ltd. | 8 | 2025-03-30 |
| Ad-Tech Medical Instrument Corp | 8 | 2006-05-25 |
| Ad-Tech Medical Instrument Corporation | 5 | 2023-05-18 |
| FHC, Inc. | 4 | 2018-12-20 |
| Alpha Omega , Ltd. | 3 | 2007-12-03 |
23 more applicants have GZL clearances. See the full list in Caduvo.
Most recent GZL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253970 | Sensomedical Labs, Ltd. | Wovyn Depth Electrode | 2026-04-17 | 127 |
| K250363 | Beijing Sinovation Medical Technology Co., Ltd. | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept | 2025-11-05 | 268 |
| K250601 | Alpha Omega Engineering , Ltd. | Neuro Omega System; NeuroSmart System | 2025-03-30 | 30 |
| K223269 | Ad-Tech Medical Instrument Corporation | Spencer Probe Depth Electrodes | 2023-05-18 | 206 |
| K223276 | Ad-Tech Medical Instrument Corporation | Anchor Bolts as Accessories to Depth Electrodes | 2023-05-18 | 206 |
Recalls for GZL devices
24 product recalls in 11 recall events; 12 initiated in the last five years and 0 still open. Most recent: 2024-09-19.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 4 |
| 2020 | 1 |
| 2021 | 9 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code GZL?
GZL is the FDA product code for electrode, depth. It is a Class II device, regulated under 21 CFR 882.1330 and reviewed by the Neurology panel.
What device class is GZL?
Class II, regulation 21 CFR 882.1330. Typical premarket route: 510(k).
How long does a 510(k) take for product code GZL?
Across 58 cleared submissions the average was 175 days from receipt to decision (median 170).
Which companies have the most GZL clearances?
Alpha Omega Engineering , Ltd. (8); Ad-Tech Medical Instrument Corp (8); Ad-Tech Medical Instrument Corporation (5); FHC, Inc. (4); Alpha Omega , Ltd. (3).
Have GZL devices been recalled?
Yes: 24 product recalls across 11 recall events; the most recent began 2024-09-19.
Next steps
- Run an FDA pathway report with predicate devices for product code GZL
- Run a recall and safety report across every GZL manufacturer
- Watch product code GZL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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