K202087 is an FDA 510(k) clearance for the DIXI Medical Microdeep Micro-Macro Depth Electrodes. This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Dixi Medical (Chaudefontaine, FR). The FDA issued a Cleared decision on November 18, 2021, 478 days after receiving the submission on July 28, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K202087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2020 |
| Decision Date | November 18, 2021 |
| Days to Decision | 478 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 |