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

    UltraCor™ Twirl™ Breast Tissue Marker

    K Number: K243642 · Decision Mar 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    34
    Review Days
    118

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    Basic Information

    Device Name
    UltraCor™ Twirl™ Breast Tissue Marker
    K Number
    K243642
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Peripheral Vascular, Inc.
    Date Received
    November 26, 2024
    Decision Date
    March 24, 2025
    Product Code
    NEU
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NEU Marker, Radiographic, Implantable

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