K222304 is an FDA 510(k) clearance for the Sonata Transcervical Fibroid Ablation System 2.2. This device is classified as a Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (Class II - Special Controls, product code KNF).
Submitted by Gynesonics, Inc. (Redwood City, US). The FDA issued a Cleared decision on November 8, 2022, 99 days after receiving the submission on August 1, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K222304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2022 |
| Decision Date | November 08, 2022 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNF - Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4160 |