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

    Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV

    K Number: K190414 · Decision Jun 14, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    5
    Review Days
    113

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    Basic Information

    Device Name
    Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
    K Number
    K190414
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Moss Tubes, Inc.
    Date Received
    February 21, 2019
    Decision Date
    June 14, 2019
    Product Code
    PIF
    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
    PIF Gastrointestinal Tubes With Enteral Specific Connectors

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    Other Clearances by Moss Tubes, Inc.

    K Number Device Name
    K990389 MOSS GASTROSTOMY TUBE
    K984628 MODIFICATION OF MOSS P.E.G. TRAY
    K984629 MOSS TUBES, INC. NASAL TUBE - MARK IV
    K984310 MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE