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

    AN3200 DOUBILET DRAIN

    K Number: K872458 · Decision Sep 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    AN3200 DOUBILET DRAIN
    K Number
    K872458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    H.W. Andersen Products, Inc.
    Date Received
    June 23, 1987
    Decision Date
    September 21, 1987
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by H.W. Andersen Products, Inc.

    K Number Device Name
    K935688 AN-10S ANDERSEN TUBE WITH STYLET
    K872460 AN3000 MAHONEY DRAIN
    K872457 AN3500 WORTH DRAIN
    K872459 AN3100 MULHOLLAND DRAIN