K211954 is an FDA 510(k) clearance for the Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid. This device is classified as a Electrode, Cortical (Class II - Special Controls, product code GYC).
Submitted by Spes Medica Srl (Battipaglia, IT). The FDA issued a Cleared decision on November 10, 2022, 505 days after receiving the submission on June 23, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1310.
| 510(k) Number | K211954 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2021 |
| Decision Date | November 10, 2022 |
| Days to Decision | 505 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 |