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

    AMT G-Tube Balloon Gastrostomy Feeding Device

    K Number: K222846 · Decision Dec 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    25
    Review Days
    453

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    Basic Information

    Device Name
    AMT G-Tube Balloon Gastrostomy Feeding Device
    K Number
    K222846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Medical Technology, Inc.
    Date Received
    September 21, 2022
    Decision Date
    December 18, 2023
    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 Applied Medical Technology, Inc.

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