K223605 is an FDA 510(k) clearance for the ControlSeal Electrode (ELSB). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Coapt (Chicago, US). The FDA issued a Cleared decision on December 30, 2022, 28 days after receiving the submission on December 2, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K223605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2022 |
| Decision Date | December 30, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |