# K211535: Sonata Transcervical Fibroid Ablation System 2.2

- Pathway: 510(k) (Special)
- Applicant: Gynesonics, Inc.
- Decided: Jun 17, 2021 after 30 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: 8 generations back to K934041 (1994). 39 ancestors in all.
4 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)
- K193516: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1, Gynesonics, Inc. (2020) Summary page 5.

## Most influential descendants
- K222304: Sonata Transcervical Fibroid Ablation System 2.2 (2022), 3 descendants of its own
- K233848: Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (2023), 2 descendants of its own
- 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 2.2 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/K211535
Methodology: https://510kreport.com/methodology