BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    MICROMANIPULATOR SET

    K Number: K120877 · Decision Jun 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    22
    Applicant Total
    20
    Review Days
    89

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    Basic Information

    Device Name
    MICROMANIPULATOR SET
    K Number
    K120877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6150
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Narishige Co., Ltd.
    Date Received
    March 23, 2012
    Decision Date
    June 20, 2012
    Product Code
    MQJ
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQJ Micromanipulators And Microinjectors, Assisted Reproduction

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    Other Clearances by Narishige Co., Ltd.

    K Number Device Name
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    K003304 IM-6 MICROINJECTOR
    K003302 IM-5A INJECTOR
    K003303 IM-5B MICROINJECTOR
    K003300 MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
    K003298 MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
    K002850 MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
    K002659 MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR
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