Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is an FDA 510(k)-cleared medical device (K193516) manufactured by Gynesonics, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 2020. Regulation: 8.