K220122 is an FDA 510(k) clearance for the APEX 6. This device is classified as a Generator, Lesion, Radiofrequency (Class II - Special Controls, product code GXD).
Submitted by Rf Innovations, Inc. (Middleton, US). The FDA issued a Cleared decision on March 15, 2023, 421 days after receiving the submission on January 18, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4400.
| 510(k) Number | K220122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2022 |
| Decision Date | March 15, 2023 |
| Days to Decision | 421 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXD - Generator, Lesion, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4400 |