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FDA 510(k) Applications Submitted by GYNESONICS, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211535
05/18/2021
Sonata Transcervical Fibroid Ablation System 2.2
Gynesonics, Inc.
K222304
08/01/2022
Sonata Transcervical Fibroid Ablation System 2.2
Gynesonics, Inc.
K173703
12/04/2017
Sonata Sonography-Guided Transcervical Fibroid Ablation System
Gynesonics, Inc.
K061153
04/26/2006
GYNESONICS EC6 TRANSDUCER
GYNESONICS, INC.
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