BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GYNESONICS, INC.

    Reg #: 3005875675 · FEI: 3005875675 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GYNESONICS, INC.
    Registration Number
    3005875675
    FEI Number
    3005875675
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    200 Cardinal Way #250
    City
    REDWOOD CITY
    State
    CA
    ZIP
    94063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222304

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Sue Dahlquist

    Products

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

    Proprietary Names

    Sonata Transcervical Fibroid Ablation System

    Establishment Types

    Manufacture Medical Device