BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sonata® Radiofrequency Ablation Handpiece

    Reg #: 3005875675 · FEI: 3005875675 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GYNESONICS, INC.
    Registration Number
    3005875675
    FEI Number
    3005875675
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 Chesapeake Drive
    City
    REDWOOD CITY
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222304

    Owner / Operator

    Firm Name
    Gynesonics
    Operator Number
    9086343
    Address
    200 Cardinal Way #250
    City
    Redwood City
    State
    CA
    Postal Code
    94063
    Country
    US
    Correspondent
    Christine - Ehmann

    Products

    Device Name Product Code
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Sonata® Radiofrequency Ablation Handpiece Sonata® Intrauterine Ultrasound Probe Return Kit Sonata® Intrauterine Ultrasound Probe, Sterile Sonata® Transcervical Fibroid Ablation System 2.2 Sonata® Intrauterine Ultrasound Probe Sterile Shipper Kit Sonata® RFA Handpiece Cable, Reusable Sonata® Intrauterine Ultrasound Probe Sonata® IUUS Probe Connector Protector Sonata® Dispersive Electrode

    Establishment Types

    Manufacture Medical Device