K191346 is an FDA 510(k) clearance for the Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids). This device is classified as a Electrode, Cortical (Class II - Special Controls, product code GYC).
Submitted by Blackrock Microsystems (Salt Lake City, US). The FDA issued a Cleared decision on February 14, 2020, 270 days after receiving the submission on May 20, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1310.
| 510(k) Number | K191346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2019 |
| Decision Date | February 14, 2020 |
| Days to Decision | 270 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 |