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

    SAPIMED DISPOSABLE SIGMOIDOSCOPE

    K Number: K070915 · Decision Jul 6, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    95

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    Basic Information

    Device Name
    SAPIMED DISPOSABLE SIGMOIDOSCOPE
    K Number
    K070915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sapimed S.P.A.
    Date Received
    April 2, 2007
    Decision Date
    July 6, 2007
    Product Code
    KDM
    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
    KDM Sigmoidoscope, Rigid, Non-Electrical

    Other Clearances by Sapimed S.P.A.

    K Number Device Name
    K070881 LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
    K070913 SELF-LIGHT DISPOSABLE ANOSCOPE