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

    KSEA UROPUMP

    K Number: K981615 · Decision Jul 8, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    27
    Applicant Total
    334
    Review Days
    63

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    Basic Information

    Device Name
    KSEA UROPUMP
    K Number
    K981615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    May 6, 1998
    Decision Date
    July 8, 1998
    Product Code
    LJH
    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
    LJH System, Irrigation, Urological

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