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

    VIVANT BREAST LESION LOCALIZATION DEVICE

    K Number: K003439 · Decision Dec 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    10
    Review Days
    39

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    Basic Information

    Device Name
    VIVANT BREAST LESION LOCALIZATION DEVICE
    K Number
    K003439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vivant Medical, Inc.
    Date Received
    November 6, 2000
    Decision Date
    December 15, 2000
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNW Instrument, Biopsy

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    Other Clearances by Vivant Medical, Inc.

    K Number Device Name
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    K032702 VIVATIP MICROWAVE ABLATION PROBE
    K032047 TRI-LOOP MICROWAVE ABLATION PROBE
    K031556 VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
    K023311 LOOP MICROWAVE ABLATION PROBE
    K022286 ENCIRCLE LOCALIZATION DEVICE
    K011676 VIVAWAVE MICROWAVE SYSTEM
    K000278 VIVANT MEDICAL BIOPSY MARKER SYSTEM