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Gynesonics, Inc.

United States·US-MF-000017044

Last updated September 17, 2026

Information

Country
United States
Address
200, Cardinal Way #250, Redwood City, United States
LinkedIn
—
Facebook
—
Phone
+1 650 241 6120
PRRC Contact
Kristin Fornieri
EUDAMED SRN
US-MF-000017044
FDA FEI Number
3005875675
DUNS Number
618493741

Catalogue (28)

DeviceModel / ReferenceRegistriesClassStatus
Sonata® Case Kit CSKIT-001
FDA UDI
Class IIUnknown
Sonata System Software SW-002
FDA UDI
Class IIActive
Sonata® System Radiofrequency Generator RFG2-110
FDA UDI
Class IIActive
Sonata® Procedure Kit PROKIT-001
FDA UDI
Class IIUnknown
Sonata® Sonography-Guided Transcervical Fibroid Ablation System SONATA2-110
FDA UDI
Class IIActive
Sonata® IUUS Probe Soaking Cylinder CYL-001
FDA UDI
Class IIUnknown
Sonata® System Software SW-001
FDA UDI
Class IIUnknown
Sonata® SMART Tablet USCON-2200
FDA UDI
Class IIActive
Sonata® IUUS Probe Leak Tester ACCY-017
FDA UDI
Class IActive
Sonata® IUUS probe Leak Tester Kit ACCY-016
FDA UDI
Class IActive
Sonata® System Cart ACCY-002
FDA UDI
Class IIActive
Sonata Sterile Shipper Kit SHPR-001
EUDAMEDFDA UDI
Class IActive
Sonata RFA Cable, reusable ACCY-008
EUDAMEDFDA UDI
Class IActive
Sonata Transcervical Fibroid Ablation System 2.2 K222304
FDA 510(k)
Class IIActive
Sonata Transcervical Fibroid Ablation System 2.2 K211535
FDA 510(k)
Class IIActive
Gynesonics Ec6 Transducer K061153
FDA 510(k)
Class IIActive
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) K233848
FDA 510(k)
Class IIActive
Sonata Transcervical Fibroid Ablation System 2.2 K240503
FDA 510(k)
Class IIActive
Sonata Transcervical Fibroid Ablation System 2.2 K250705
FDA 510(k)
Class IIActive
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 K193516
FDA 510(k)
Class IIActive
Sonata Sonography-Guided Transcervical Fibroid Ablation System K173703
FDA 510(k)
Class IIActive
Sonata Intrauterine Ultrasound Probe, sterile IUSP-002S
EUDAMEDFDA UDI
Class IIaActive
Sonata IUUS Probe Connector Protector ACCY-018
EUDAMEDFDA UDI
Class IActive
Sonata IUUS Probe Return Kit RTN-001
EUDAMEDFDA UDI
Class IActive
Sonata Intrauterine Ultrasound Probe, non-sterile IUSP-002
EUDAMEDFDA UDI
Class IIaActive
Sonata Dispersive Electrode DE-002
EUDAMEDFDA UDI
Class IIbActive
Sonata® Transcervical Fibroid Ablation System SONATA2-220
EUDAMED
Class IIbActive
Sonata Radiofrequency Ablation Handpiece RFA-002
EUDAMEDFDA UDI
Class IIbActive

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