K250705
- 510(k) number
- K250705
- Device name
- Sonata Transcervical Fibroid Ablation System 2.2
- Applicant
- Gynesonics, Inc. CA · US
- Product code
- KNF — Coagulator-Cutter, Endoscopic, Unipolar (And Accesso
- Decision date
- 2025-04-02
- Date received
- 2025-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250705.pdf
Official FDA record: K250705
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.