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

    ENSIZOR ENDOSCOPIC SCISSORS

    K Number: K141058 · Decision Aug 1, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    72
    Applicant Total
    2
    Review Days
    99

    Basic Information

    Device Name
    ENSIZOR ENDOSCOPIC SCISSORS
    K Number
    K141058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SLATER ENDOSCOPY, LLC
    Date Received
    April 24, 2014
    Decision Date
    August 1, 2014
    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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