K201931 is an FDA 510(k) clearance for the Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids). This device is classified as a Electrode, Cortical (Class II - Special Controls, product code GYC).
Submitted by Dixi Medical (Chaudefontaine, FR). The FDA issued a Cleared decision on October 2, 2021, 446 days after receiving the submission on July 13, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1310.
| 510(k) Number | K201931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2020 |
| Decision Date | October 02, 2021 |
| Days to Decision | 446 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYC - Electrode, Cortical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1310 |