510(k) K193516 · KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
| Applicant | Gynesonics, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, May 4, 2020 |
| Received | Dec 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193516
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.