SENSOSEEG Depth Electrodes
FDA 510(k) K213170 · Sensomedical Labs, Ltd.
510(k) numberK213170
Submission
- Device name
- SENSOSEEG Depth Electrodes
- Applicant
- Sensomedical Labs, Ltd.
Nazareth, IL - Received
- September 28, 2021
- Decision date
- April 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253970 | Wovyn Depth ElectrodeGZL · Traditional | Sensomedical Labs, Ltd. | 04/17/2026SE |
| K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth…GZL · Traditional | Beijing Sinovation Medical Technology Co., Ltd. | 11/05/2025SE |
| K250601 | Neuro Omega System; NeuroSmart SystemGZL · Special | Alpha Omega Engineering , Ltd. | 03/30/2025SE |
| K223276 | Anchor Bolts as Accessories to Depth ElectrodesGZL · Traditional | Ad-Tech Medical Instrument Corporation | 05/18/2023SE |
| K223269 | Spencer Probe Depth ElectrodesGZL · Traditional | Ad-Tech Medical Instrument Corporation | 05/18/2023SE |
| K222706 | iCE-SG2 Subcutaneous Electrode KitGZL · Traditional | Ice Neurosystems, Inc. | 12/06/2022SE |
| K222404 | Evo® sEEG SystemGZL · Traditional | Neuroone Medical Technologies Corp. | 10/20/2022SE |
| K220553 | Neuro Omega System, NeuroSmart SystemGZL · Special | Alpha Omega Engineering , Ltd. | 09/16/2022SE |
| K202087 | DIXI Medical Microdeep Micro-Macro Depth ElectrodesGZL · Traditional | Dixi Medical | 11/18/2021SE |
| K211367 | Evo sEEG SystemGZL · Traditional | Neuroone Medical Technologies Corp. | 09/01/2021SE |
More from Neuroone Medical Technologies Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K253970 | Wovyn Depth ElectrodeGZL · Traditional | 04/17/2026SE |
Questions and answers
When was SENSOSEEG Depth Electrodes cleared by the FDA?
SENSOSEEG Depth Electrodes (K213170) received a 510(k) decision of Substantially Equivalent on April 18, 2023, 567 days after the submission was received.
What is the product code of K213170?
The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.