About This 510(k) Submission
K173703 is an FDA 510(k) clearance for the Sonata Sonography-Guided Transcervical Fibroid Ablation System, a Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code KNF), submitted by Gynesonics, Inc. (Redwood City, US). The FDA issued a Cleared decision on August 15, 2018, 254 days after receiving the submission on December 4, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.