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

    MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM

    K Number: K072684 · Decision Jan 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM
    K Number
    K072684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mondeal North America, Inc.
    Date Received
    September 21, 2007
    Decision Date
    January 4, 2008
    Product Code
    OCZ
    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
    OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

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