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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K173703
Device Name Sonata Sonography-Guided Transcervical Fibroid Ablation System
Applicant
Gynesonics, Inc.
301 Galveston Dr.
Redwood City,  CA  94063
Applicant Contact Diane King
Correspondent
Gynesonics, Inc.
600 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact Diane King
Regulation Number884.4160
Classification Product Code
KNF  
Subsequent Product Codes
ITX   IYO  
Date Received12/04/2017
Decision Date 08/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT02228174
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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