> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Gynesonics’ Sonata Fibroid Ablation System Cleared
- URL: https://www.fdaweb.com/gynesonics-sonata-fibroid-ablation-system-cleared/
- Published: 2018-08-22T12:00:00.000Z
- Updated: 2026-09-15T00:27:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142180

FDA has cleared a Gynesonics 510(k) to market its Sonata Sonography-Guided Transcervical Fibroid Ablation System. The ultrasound system with a proprietary radiofrequency ablation device “provides a transcervical, incision-free, uterus-preserving treatment for uterine fibroids,” the company says. The device exceeded “FDA-specified 12-month primary endpoint performance requirements for the Sonata System in the SONATA pivotal IDE clinical trial used to support the FDA regulatory 510(k) filing,” it says. Co-primary endpoints included a significant reduction in bleeding and a high rate of freedom from surgical reintervention due to heavy menstrual bleeding. And safety outcomes were also favorable, including zero device-related adverse events reported in the 147-patient trial.