K053358 is an FDA 510(k) clearance for the DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES. This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Ad-Tech Medical Instrument Corp (Stoughton, US). The FDA issued a Cleared decision on May 25, 2006, 174 days after receiving the submission on December 2, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K053358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2005 |
| Decision Date | May 25, 2006 |
| Days to Decision | 174 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZL — Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |