BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    INSERTEASE

    K Number: K092829 · Decision Dec 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    78

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    Basic Information

    Device Name
    INSERTEASE
    K Number
    K092829
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.4730
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Christcot Medical Company
    Date Received
    September 15, 2009
    Decision Date
    December 2, 2009
    Product Code
    OOW
    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
    OOW Applicator For Rectal Suppository