GZL · Electrode, Depth
Neurology · 21 CFR 882.1330 · Class 2
Overview
| Product Code | GZL |
|---|---|
| Device Name | Electrode, Depth |
| Regulation | 21 CFR 882.1330 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | Apr 17, 2026 | SESE |
| K250363 | 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 | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering , Ltd. | Mar 30, 2025 | SESE |
| K223276 | Anchor Bolts as Accessories to Depth Electrodes | Ad-Tech Medical Instrument Corporation | May 18, 2023 | SESE |
| K223269 | Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | May 18, 2023 | SESE |
| K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | Apr 18, 2023 | SESE |
| K222706 | iCE-SG2 Subcutaneous Electrode Kit | Ice Neurosystems, Inc. | Dec 6, 2022 | SESE |
| K222404 | Evo® sEEG System | Neuroone Medical Technologies Corp. | Oct 20, 2022 | SESE |
| K220553 | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering , Ltd. | Sep 16, 2022 | SESE |
| K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes | Dixi Medical | Nov 18, 2021 | SESE |
| K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | Sep 1, 2021 | SESE |
| K201678 | iCE-SG Subcutaneous Electrode Arrays | Ice Neurosystems, Inc. | Mar 8, 2021 | SESE |
| K191739 | Sterile LeadConfirm | Alpha Omega Engineering , Ltd. | Jan 2, 2020 | SESE |
| K183123 | microTargeting Guideline 4000 5.0 System | FHC, Inc. | Dec 20, 2018 | SESE |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | Ad-Tech Medical Instrument Corporation | Aug 9, 2018 | SESE |
| K172042 | NeuroNav System, NeuroSmart System | Alpha Omega Engineering , Ltd. | Feb 27, 2018 | SESE |
| K171581 | Neuro Omega System | Alpha Omega Engineering , Ltd. | Dec 22, 2017 | SESE |
| K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | Nov 24, 2017 | SESE |
| K162459 | AccuPoint Electrode | Microprobes For Life Science, Inc. Dba Neuron | Jun 15, 2017 | SESE |
| K163355 | 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
