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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10817929020340 K193516 000
10817929020166 K193516 000

Trademark Results [Sonata]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SONATA
SONATA
97852234 not registered Live/Pending
Greenhouse Grown Foods Inc.
2023-03-22
SONATA
SONATA
97558467 not registered Live/Pending
Orthofix US LLC
2022-08-22
SONATA
SONATA
97491975 not registered Live/Pending
SONATA SOFTWARE LIMITED
2022-07-07
SONATA
SONATA
97440953 not registered Live/Pending
Oliveros, Inc
2022-06-02
SONATA
SONATA
97346612 not registered Live/Pending
WENTE BROS.
2022-04-05
SONATA
SONATA
90763809 not registered Live/Pending
Inaugural Financial, Inc.
2021-06-09
SONATA
SONATA
90110226 not registered Live/Pending
Goldstein, Ira
2020-08-12
SONATA
SONATA
90110226 not registered Live/Pending
Goldstein, David
2020-08-12
SONATA
SONATA
88416926 not registered Live/Pending
Shanghai Yu'an Electronic Technology Co., Ltd.
2019-05-06
SONATA
SONATA
88026760 not registered Live/Pending
CORTOPASSI FAMILY TRUST
2018-07-05
SONATA
SONATA
87721225 5519151 Live/Registered
Hub Pen Company LLC
2017-12-14
SONATA
SONATA
87368608 5273154 Live/Registered
Kooapps
2017-03-13

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