BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    BrachyGel Vaginal Hydrogel Packing System

    K Number: DEN220052 · Decision Aug 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    362

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    Basic Information

    Device Name
    BrachyGel Vaginal Hydrogel Packing System
    K Number
    DEN220052
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.5735
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Brachyfoam, Inc. D/B/A Advaray
    Date Received
    August 25, 2022
    Decision Date
    August 22, 2023
    Product Code
    QXR
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QXR Vaginal Hydrogel Packing System