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

    WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR

    K Number: K011178 · Decision May 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    10
    Applicant Total
    125
    Review Days
    17

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    Basic Information

    Device Name
    WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
    K Number
    K011178
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    April 17, 2001
    Decision Date
    May 4, 2001
    Product Code
    LQC
    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
    LQC Lithotriptor, Biliary Mechanical

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