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510(k) Data Aggregation

    K Number
    K041544
    Device Name
    COOK SIDEARM CORE TISSUE BIOPSY DEVICE
    Manufacturer
    UROLOGICAL INC.
    Date Cleared
    2004-07-22

    (43 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROLOGICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple cores of tissue sampling from sites including, but not limited to the prostate, kidney, liver, lung, breast, lymph nodes, and different tumors for histological evaluation.
    Device Description
    The Cook® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple core tissue sampling from sites including, but not limited to, the prostate, kidney, liver, lung, breast, lymph nodes and different tumors for histological evaluation. The Cook® Sidearm Core Tissue Biopsy Device/Set allows adjustment for an 18mm or 23mm sample, allows the sample to be easily exposed, is a one-handed operation, and will not fire when the sample size is in the incorrect position. The construction of the Cook® Sidearm Core Tissue Biopsy Device is Ryton, Anodized aluminum, Silicone, Delrin, and Stainless Steel. The construction of the Cook® Sidearm Needles are stainless steel and polycarbonate.
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