# K233848: Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)

- Pathway: 510(k) (Special)
- Applicant: Gynesonics, Inc.
- Decided: Dec 21, 2023 after 16 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: 10 generations back to K934041 (1994). 41 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222304: Sonata Transcervical Fibroid Ablation System 2.2, Gynesonics, Inc. (2022) Summary page 5.

## Most influential descendants
- K240503: Sonata Transcervical Fibroid Ablation System 2.2 (2024), 1 descendant of its own
- K250705: Sonata Transcervical Fibroid Ablation System 2.2 (2025), 0 descendants of its own

## 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/K233848
Methodology: https://510kreport.com/methodology