Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)

Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) is an FDA 510(k)-cleared medical device (K233848) 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 December 20, 2023. Regulation: 8.