GZL — Electrode, Depth Class II
FDA Device Classification
Classification Details
- Product Code
- GZL
- Device Class
- Class II
- Regulation Number
- 882.1330
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250363 | beijing sinovation medical technology co | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12 | November 5, 2025 |
| K250601 | alpha omega engineering | Neuro Omega System; NeuroSmart System | March 30, 2025 |
| K223276 | ad-tech medical instrument corporation | Anchor Bolts as Accessories to Depth Electrodes | May 18, 2023 |
| K223269 | ad-tech medical instrument corporation | Spencer Probe Depth Electrodes | May 18, 2023 |
| K213170 | sensomedical labs | SENSOSEEG Depth Electrodes | April 18, 2023 |
| K222706 | ice neurosystems | iCE-SG2 Subcutaneous Electrode Kit | December 6, 2022 |
| K222404 | neuroone medical technologies | Evo® sEEG System | October 20, 2022 |
| K220553 | alpha omega engineering | Neuro Omega System, NeuroSmart System | September 16, 2022 |
| K202087 | dixi medical | DIXI Medical Microdeep Micro-Macro Depth Electrodes | November 18, 2021 |
| K211367 | neuroone medical technologies | Evo sEEG System | September 1, 2021 |
| K201678 | ice neurosystems | iCE-SG Subcutaneous Electrode Arrays | March 8, 2021 |
| K191739 | alpha omega engineering | Sterile LeadConfirm | January 2, 2020 |
| K183123 | fhc | microTargeting Guideline 4000 5.0 System | December 20, 2018 |
| K181544 | ad-tech medical instrument corporation | Anchor Bolt (as an accessory to Depth Electrodes) | August 9, 2018 |
| K172042 | alpha omega engineering | NeuroNav System, NeuroSmart System | February 27, 2018 |
| K171581 | alpha omega engineering | Neuro Omega System | December 22, 2017 |
| K170959 | dixi medical | DIXI Medical Microdeep Depth Electrode | November 24, 2017 |
| K162459 | microprobes for life science, inc. dba neuron | AccuPoint Electrode | June 15, 2017 |
| K163355 | ad-tech medical instrument corporation | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, S | April 12, 2017 |
| K151790 | pmt corporation | PMT Platinum Depthalon Depth Electrode | July 14, 2016 |