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 IDK193516
510k NumberK193516
Device Name:Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
ClassificationCoagulator-cutter, Endoscopic, Unipolar (and Accessories)
Applicant Gynesonics, Inc 600 Chesapeake Drive Redwood City,  CA  94063
ContactDiane King
CorrespondentDiane King
Gynesonics, Inc 600 Chesapeake Drive Redwood City,  CA  94063
Product CodeKNF  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number884.4160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-19
Decision Date2020-05-04

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