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

    ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE

    K Number: K130611 · Decision Dec 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    3
    Review Days
    287

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    Basic Information

    Device Name
    ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
    K Number
    K130611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xeridiem Medical Devices
    Date Received
    March 7, 2013
    Decision Date
    December 19, 2013
    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 Xeridiem Medical Devices

    K Number Device Name
    K171347 Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
    K130674 ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE