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

    MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE

    K Number: K984310 · Decision Feb 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    5
    Review Days
    84

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    Basic Information

    Device Name
    MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE
    K Number
    K984310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Moss Tubes, Inc.
    Date Received
    December 2, 1998
    Decision Date
    February 24, 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 Moss Tubes, Inc.

    K Number Device Name
    K190414 Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
    K990389 MOSS GASTROSTOMY TUBE
    K984628 MODIFICATION OF MOSS P.E.G. TRAY
    K984629 MOSS TUBES, INC. NASAL TUBE - MARK IV