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

    GIP/MED-GLOBE STONE EXTRACTOR BASKETS

    K Number: K942005 · Decision Nov 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    37
    Applicant Total
    18
    Review Days
    211

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    Basic Information

    Device Name
    GIP/MED-GLOBE STONE EXTRACTOR BASKETS
    K Number
    K942005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medi-Globe Corp.
    Date Received
    April 25, 1994
    Decision Date
    November 22, 1994
    Product Code
    LQR
    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
    LQR Dislodger, Stone, Biliary

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