510(k) K211535

Sonata Transcervical Fibroid Ablation System 2.2 by Gynesonics, Inc. — Product Code KNF

K211535 is an FDA 510(k) premarket notification submitted by Gynesonics, Inc. for the device "Sonata Transcervical Fibroid Ablation System 2.2". The FDA issued a decision of Substantially Equivalent on June 17, 2021. 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.