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

    OSTOMY IRRIGATION SET

    K Number: K121833 · Decision Jul 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    11
    Applicant Total
    71
    Review Days
    24

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    Basic Information

    Device Name
    OSTOMY IRRIGATION SET
    K Number
    K121833
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5895
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coloplast A/S
    Date Received
    June 22, 2012
    Decision Date
    July 16, 2012
    Product Code
    EXD
    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
    EXD Irrigator, Ostomy

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