Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1330](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1330) → GZL — Electrode, Depth # GZL · Electrode, Depth _Neurology · 21 CFR 882.1330 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL ## Overview - **Product Code:** GZL - **Device Name:** Electrode, Depth - **Regulation:** [21 CFR 882.1330](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1330) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 58) Showing 20 most recent of 58 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253970](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K253970.md) | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | Apr 17, 2026 | SESE | | [K250363](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K250363.md) | 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 | Beijing Sinovation Medical Technology Co., Ltd. | Nov 5, 2025 | SESE | | [K250601](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K250601.md) | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering , Ltd. | Mar 30, 2025 | SESE | | [K223276](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K223276.md) | Anchor Bolts as Accessories to Depth Electrodes | Ad-Tech Medical Instrument Corporation | May 18, 2023 | SESE | | [K223269](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K223269.md) | Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | May 18, 2023 | SESE | | [K213170](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K213170.md) | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | Apr 18, 2023 | SESE | | [K222706](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K222706.md) | iCE-SG2 Subcutaneous Electrode Kit | Ice Neurosystems, Inc. | Dec 6, 2022 | SESE | | [K222404](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K222404.md) | Evo® sEEG System | Neuroone Medical Technologies Corp. | Oct 20, 2022 | SESE | | [K220553](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K220553.md) | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering , Ltd. | Sep 16, 2022 | SESE | | [K202087](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K202087.md) | DIXI Medical Microdeep Micro-Macro Depth Electrodes | Dixi Medical | Nov 18, 2021 | SESE | | [K211367](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K211367.md) | Evo sEEG System | Neuroone Medical Technologies Corp. | Sep 1, 2021 | SESE | | [K201678](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K201678.md) | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | Mar 8, 2021 | SESE | | [K191739](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K191739.md) | Sterile LeadConfirm | Alpha Omega Engineering , Ltd. | Jan 2, 2020 | SESE | | [K183123](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K183123.md) | microTargeting Guideline 4000 5.0 System | FHC, Inc. | Dec 20, 2018 | SESE | | [K181544](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K181544.md) | Anchor Bolt (as an accessory to Depth Electrodes) | Ad-Tech Medical Instrument Corporation | Aug 9, 2018 | SESE | | [K172042](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K172042.md) | NeuroNav System, NeuroSmart System | Alpha Omega Engineering , Ltd. | Feb 27, 2018 | SESE | | [K171581](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K171581.md) | Neuro Omega System | Alpha Omega Engineering , Ltd. | Dec 22, 2017 | SESE | | [K170959](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K170959.md) | DIXI Medical Microdeep Depth Electrode | Dixi Medical | Nov 24, 2017 | SESE | | [K162459](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K162459.md) | AccuPoint Electrode | Microprobes For Life Science, Inc. Dba Neuron | Jun 15, 2017 | SESE | | [K163355](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K163355.md) | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | Apr 12, 2017 | SESE | ## Top Applicants - Ad-Tech Medical Instrument Corp — 8 clearances - Alpha Omega Engineering , Ltd. — 8 clearances - Ad-Tech Medical Instrument Corporation — 5 clearances - FHC, Inc. — 4 clearances - Alpha Omega , Ltd. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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