Anchor Bolts as Accessories to Depth Electrodes
FDA 510(k) K223276 · Ad-Tech Medical Instrument Corporation
510(k) numberK223276
Submission
- Device name
- Anchor Bolts as Accessories to Depth Electrodes
- Applicant
- Ad-Tech Medical Instrument Corporation
Oak Creek, WI, US - Received
- October 24, 2022
- Decision date
- May 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 |
| K223269 | Spencer Probe Depth ElectrodesGZL · Traditional | Ad-Tech Medical Instrument Corporation | 05/18/2023SE |
| K213170 | SENSOSEEG Depth ElectrodesGZL · Traditional | Sensomedical Labs, Ltd. | 04/18/2023SE |
| 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 |
|---|---|---|
| K223269 | Spencer Probe Depth ElectrodesGZL · Traditional | 05/18/2023SE |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…GYC · Traditional | 01/25/2020SE |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes)GZL · Traditional | 08/09/2018SE |
| K170442 | Cranial Drill Bits and AccessoriesHBE · Traditional | 09/07/2017SE |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…GZL · Traditional | 04/12/2017SE |
| K152769 | Fremap ElectrodeETN · Traditional | 05/06/2016SE |
| K152547 | DNAP ElectrodeGZL · Traditional | 03/04/2016SE |
| K112094 | Brain Biopsy NeedleHAW · Traditional | 04/24/2012SE |
| K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes…GYC · Abbreviated | 05/30/2006SE |
| K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesGZL · Abbreviated | 05/25/2006SE |
Questions and answers
When was Anchor Bolts as Accessories to Depth Electrodes cleared by the FDA?
Anchor Bolts as Accessories to Depth Electrodes (K223276) received a 510(k) decision of Substantially Equivalent on May 18, 2023, 206 days after the submission was received.
What is the product code of K223276?
The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.