# K250705: Sonata Transcervical Fibroid Ablation System 2.2

- Pathway: 510(k) (Special)
- Applicant: Gynesonics, Inc.
- Decided: Apr 2, 2025 after 23 days
- Product code: KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K934041 (1994). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240503: Sonata Transcervical Fibroid Ablation System 2.2, Gynesonics, Inc. (2024) Summary page 5.

## Indications for use
The Sonata® Transcervical Fibroid Ablation System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

Source page: https://510kreport.com/device/K250705
Methodology: https://510kreport.com/methodology