K193516 is an FDA 510(k) clearance for the Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1. 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 May 4, 2020, 137 days after receiving the submission on December 19, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K193516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2019 |
| Decision Date | May 04, 2020 |
| Days to Decision | 137 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 |