Anchor Bolt (as an accessory to Depth Electrodes)
FDA 510(k) K181544 · Ad-Tech Medical Instrument Corporation
510(k) numberK181544
Submission
- Device name
- Anchor Bolt (as an accessory to Depth Electrodes)
- Applicant
- Ad-Tech Medical Instrument Corporation
Oak Creek, WI, US - Received
- June 12, 2018
- Decision date
- August 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K220553 | Neuro Omega System, NeuroSmart SystemGZL · Special | Alpha Omega Engineering , Ltd. | 09/16/2022SE |
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More from Dixi Medical
| 510(k) | Device | Decision |
|---|---|---|
| K223276 | Anchor Bolts as Accessories to Depth ElectrodesGZL · Traditional | 05/18/2023SE |
| K223269 | Spencer Probe Depth ElectrodesGZL · Traditional | 05/18/2023SE |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…GYC · Traditional | 01/25/2020SE |
| 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 Bolt (as an accessory to Depth Electrodes) cleared by the FDA?
Anchor Bolt (as an accessory to Depth Electrodes) (K181544) received a 510(k) decision of Substantially Equivalent on August 9, 2018, 58 days after the submission was received.
What is the product code of K181544?
The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.