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

    MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE

    K Number: K990863 · Decision Apr 6, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    4
    Review Days
    21

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    Basic Information

    Device Name
    MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
    K Number
    K990863
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ross Product Div. Abbott Laboratories
    Date Received
    March 16, 1999
    Decision Date
    April 6, 1999
    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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    Other Clearances by Ross Product Div. Abbott Laboratories

    K Number Device Name
    K031407 ROSS EMBRACE ENTERAL PUMP
    K003047 AMBULATORY ENTERAL NUTRITION PUMP
    K992494 FLEXIFLO ENTERAL FEEDING TUBE