GZL — Electrode, Depth Class II
FDA product code GZL covers "Electrode, Depth", a Class II medical device regulated under 21 CFR 882.1330. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253970 | sensomedical labs | Wovyn Depth Electrode | April 17, 2026 |
| 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 |