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# Gynesonics Sonata Fibroid Device Cleared
- URL: https://www.fdaweb.com/gynesonics-sonata-fibroid-device-cleared/
- Published: 2021-09-16T12:00:00.000Z
- Updated: 2026-09-14T17:14:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150162

FDA has cleared a Gynesonics 510(k) for the Sonata System 2.2 for treating fibroids. The company says the new device features a 20% reduction in the smallest ablation size setting, which increases the ability to treat fibroids in tighter anatomical locations. The device also has new software that allows a surgeon to control all aspects of the ablation from the handpiece without requiring operating room staff to separately adjust settings, according to the company. Additionally, the device’s intrauterine ultrasound reusable probe is said to be validated to be sterilized using the Steris V-Pro low temperature sterilization systems. Fibroids are benign growths in or around the uterus.