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

    PERCUTANEOUS GASTROSTOMY TUBE

    K Number: K842174 · Decision Dec 7, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    1
    Review Days
    184

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    Basic Information

    Device Name
    PERCUTANEOUS GASTROSTOMY TUBE
    K Number
    K842174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mount Carmel Mercy Hospital
    Date Received
    June 6, 1984
    Decision Date
    December 7, 1984
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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