Sonata Sonography-Guided Transcervical Fibroid Ablation System

Sonata Sonography-Guided Transcervical Fibroid Ablation System is an FDA 510(k)-cleared medical device (K173703) 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 August 14, 2018. Regulation: 8.