# K173703: Sonata Sonography-Guided Transcervical Fibroid Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Gynesonics, Inc.
- Decided: Aug 15, 2018 after 254 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: 6 generations back to K934041 (1994). 37 ancestors in all.
6 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)
- K121858: The Ablation System, Halt Medical, Inc. (2012) Summary page 5.
- K061153: Gynesonics EC6 Transducer, Gynesonics, Inc. (2006) Summary page 5.
- K110020: Terason T3200 Ultrasound System, Teratech Corp. (2011) Summary page 5.

## Most influential descendants
- K193516: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (2020), 5 descendants of its own
- K211535: Sonata Transcervical Fibroid Ablation System 2.2 (2021), 4 descendants of its own
- 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

## Indications for use
The Sonata® Sonography-Guided 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/K173703
Methodology: https://510kreport.com/methodology