K163355 is an FDA 510(k) clearance for the Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes. This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Ad-Tech Medical Instrument Corporation (Racine, US). The FDA issued a Cleared decision on April 12, 2017, 133 days after receiving the submission on November 30, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K163355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2016 |
| Decision Date | April 12, 2017 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZL - Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |