BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE

    K Number: K050578 · Decision Apr 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    32
    Review Days
    46

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    Basic Information

    Device Name
    COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
    K Number
    K050578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Ireland, Ltd.
    Date Received
    March 7, 2005
    Decision Date
    April 22, 2005
    Product Code
    KNS
    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
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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