510(k) K173703

Sonata Sonography-Guided Transcervical Fibroid Ablation System by Gynesonics, Inc. — Product Code KNF

K173703 is an FDA 510(k) premarket notification submitted by Gynesonics, Inc. for the device "Sonata Sonography-Guided Transcervical Fibroid Ablation System". The FDA issued a decision of Substantially Equivalent on August 15, 2018. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Gynesonics, Inc. has at least 7 other 510(k) clearances on record.