Gynesonics Inc

FDA Filings

This page includes the latest FDA filings for Gynesonics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005875675
FEI Number3005875675
NameGYNESONICS, INC.
Owner & OperatorGynesonics
Contact Address600 Chesapeake Drive
Redwood City CA 94063 US
Official Correspondent
  • Diane - King
  • x-650-2163883-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address600 Chesapeake Drive
REDWOOD CITY, CA 94063 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Gynesonics, Inc
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.12020-05-04
GYNESONICS, INC.
Sonata® Intrauterine Ultrasound Probe IUSP-0022020-04-16
GYNESONICS, INC.
Sonata® Intrauterine Ultrasound Probe IUSP-002S2020-04-16
GYNESONICS, INC.
Sonata® IUUS Probe Sterile Shipper Kit SHPR-0012019-11-08
GYNESONICS, INC.
Sonata® Sonography-Guided Transcervical Fibroid Ablation System SONATA2-1102019-05-20
GYNESONICS, INC.
Sonata® System Radiofrequency Generator RFG2-1102019-05-20
GYNESONICS, INC.
Sonata® SMART Tablet USCON-22002019-05-20
GYNESONICS, INC.
Sonata® System Cart ACCY-0022019-05-20
GYNESONICS, INC.
Sonata® IUUS Probe Soaking Cylinder CYL-0012019-05-20
GYNESONICS, INC.
Sonata® Case Kit CSKIT-0012019-05-20
GYNESONICS, INC. [Gynesonics]
Sonata? Sonography-Guided Transcervical Fibroid Ablation System2018-09-18
GYNESONICS, INC. [Gynesonics]
Sonata? Sonography-Guided Transcervical Fibroid Ablation System2018-09-18
GYNESONICS, INC. [Gynesonics]
Sonata? Sonography-Guided Transcervical Fibroid Ablation System2018-09-18
Gynesonics, Inc.
Sonata Sonography-Guided Transcervical Fibroid Ablation System2018-08-15
GYNESONICS, INC.
GYNESONICS EC6 TRANSDUCER2006-10-27

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