K211367 is an FDA 510(k) clearance for the Evo sEEG System. This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Neuroone Medical Technologies Corp. (Eden Prairie, US). The FDA issued a Cleared decision on September 1, 2021, 120 days after receiving the submission on May 4, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K211367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2021 |
| Decision Date | September 01, 2021 |
| Days to Decision | 120 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 |