K233848
- 510(k) number
- K233848
- Device name
- Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
- Applicant
- Gynesonics, Inc. CA · US
- Product code
- KNF — Coagulator-Cutter, Endoscopic, Unipolar (And Accesso
- Decision date
- 2023-12-21
- Date received
- 2023-12-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233848.pdf
Official FDA record: K233848
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.