K240503
- 510(k) number
- K240503
- 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
- 2024-07-17
- Date received
- 2024-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240503.pdf
Official FDA record: K240503
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.