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# FDA Clears Gynesonics Fibroid Ablation Device
- URL: https://www.fdaweb.com/fda-clears-gynesonics-fibroid-ablation-device/
- Published: 2020-05-28T12:00:00.000Z
- Updated: 2026-09-14T16:16:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146885

FDA has cleared a Gynesonics 510(k) to market its next generation Sonata System 2.1 for Transcervical Fibroid Ablation. The device integrates an intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device to provide an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids, according to the company. It features a new integrated treatment design that enables all procedure steps to be performed on a sterile field and in the palm of the physician’s hand. Gynesonics says it also has an ergonomic radio-frequency ablation handpiece with improved controls.