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

    MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS

    K Number: K053322 · Decision Jan 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    2
    Review Days
    37

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    Basic Information

    Device Name
    MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
    K Number
    K053322
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roei Medical Technologies, Ltd.
    Date Received
    November 30, 2005
    Decision Date
    January 6, 2006
    Product Code
    FAS
    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
    FAS Electrode, Electrosurgical, Active, Urological

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    Other Clearances by Roei Medical Technologies, Ltd.

    K Number Device Name
    K050910 ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS