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

    TUBE GASTROSTOMY

    K Number: K903086 · Decision Nov 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    5
    Review Days
    131

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    Basic Information

    Device Name
    TUBE GASTROSTOMY
    K Number
    K903086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Knight Medical, Inc.
    Date Received
    July 12, 1990
    Decision Date
    November 20, 1990
    Product Code
    KGC
    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
    KGC Tube, Gastro-Enterostomy

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