K220735 is an FDA 510(k) clearance for the Avologi Gel Primer (Model: Av25). This device is classified as a Media, Electroconductive (Class II - Special Controls, product code GYB).
Submitted by Premier North America, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on September 15, 2023, 550 days after receiving the submission on March 14, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1275.
| 510(k) Number | K220735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2022 |
| Decision Date | September 15, 2023 |
| Days to Decision | 550 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYB - Media, Electroconductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1275 |