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

    L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE

    K Number: K897181 · Decision Mar 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    58
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
    K Number
    K897181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Intl. Medical Marketing, Inc.
    Date Received
    December 28, 1989
    Decision Date
    March 27, 1990
    Product Code
    FPD
    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
    FPD Tube, Feeding

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    Other Clearances by Intl. Medical Marketing, Inc.

    K Number Device Name
    K895824 L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET
    K896621 L.T.C. REPLACEMENT GASTROSTOMY TUBE
    K895957 L.T.C. 1000 URINARY DRAINAGE BAG
    K895616 L.T.C. FEEDING TUBE