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

    TRUMP-IT II AND MAGNUM 250

    K Number: K973814 · Decision Jan 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    3
    Review Days
    115

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    Basic Information

    Device Name
    TRUMP-IT II AND MAGNUM 250
    K Number
    K973814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Valley West, Inc.
    Date Received
    October 7, 1997
    Decision Date
    January 30, 1998
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Valley West, Inc.

    K Number Device Name
    K990447 1000 PRESSURE INFUSION SIGMACON 1000
    K980089 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000