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

    ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE

    K Number: K901134 · Decision Jun 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    3
    Review Days
    100

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    Basic Information

    Device Name
    ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE
    K Number
    K901134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Fresenius Pharma
    Date Received
    March 12, 1990
    Decision Date
    June 20, 1990
    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 Fresenius Pharma

    K Number Device Name
    K914216 FRENTA II+ ENTERAL FEEDING PUMP
    K901130 ENTERA-FLO FEEDING TUBE