Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

Gynesonics, Inc

The following data is part of a premarket notification filed by Gynesonics, Inc with the FDA for Sonata® Sonography-guided Transcervical Fibroid Ablation System 2.1.

Pre-market Notification Details

• Device ID: K193516
• 510k Number: K193516
• Device Name: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
• Classification: Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
• Applicant: Gynesonics, Inc 600 Chesapeake Drive Redwood City, CA 94063
• Contact: Diane King
• Correspondent: Diane King; Gynesonics, Inc 600 Chesapeake Drive Redwood City, CA 94063
• Product Code: KNF
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• CFR Regulation Number: 884.4160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-19
• Decision Date: 2020-05-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10817929020340	K193516	000
10817929020166	K193516	000