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

    STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM

    K Number: K973215 · Decision Nov 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    4
    Review Days
    71

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    Basic Information

    Device Name
    STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM
    K Number
    K973215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laurus Medical Corp.
    Date Received
    August 27, 1997
    Decision Date
    November 6, 1997
    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 Laurus Medical Corp.

    K Number Device Name
    K973415 CURVILINEAR SUTURE PLACEMENT SYSTEM
    K960317 LAURUS NEEDLE CORE BIOPSY SYSTEM
    K932553 DISPOSABLE SUTURE PLACEMENT SYSTEM