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510(k) Data Aggregation

    K Number
    K120877
    Device Name
    MICROMANIPULATOR SET
    Manufacturer
    NARISHIGE CO., LTD.
    Date Cleared
    2012-06-20

    (89 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NARISHIGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NAI-5 Micromanipulator Set enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures.
    Device Description
    The NAI-5 Micromanipulator Set enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures. The NAI-5 Micromanipulator Set consists of motor driven coarse manipulators that enable coarse movement operation and oil hydraulic micromanipulators that enable fine movement operation.
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    K Number
    K113712
    Device Name
    IM-11 PNEUMATIC MICROINJECTOR
    Manufacturer
    NARISHIGE CO., LTD.
    Date Cleared
    2012-03-15

    (87 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NARISHIGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.
    Device Description
    The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure. The IM-11 Pneumatic Microinjector is a manually operated pneumatically actuated screw driven microinjector incorporating coarse and fine control knobs. The coarse control knob is used to perform coarse movement operation while the fine control knob is used to perform fine movement operation. It is easy to use simply by turning the control knob clockwise for injection and counterclockwise for aspiration. The IM-11 Pneumatic Microinjector is a component part of a micromanipulator system.
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    K Number
    K011420
    Device Name
    MM-87 MOTOR-DRIVE MANIPULATOR
    Manufacturer
    NARISHIGE CO., LTD.
    Date Cleared
    2001-06-12

    (34 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NARISHIGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010298
    Device Name
    MN-4 COARSE MANIPULATOR
    Manufacturer
    NARISHIGE CO., LTD.
    Date Cleared
    2001-03-16

    (44 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NARISHIGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003300
    Device Name
    MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
    Manufacturer
    NARISHIGE CO., LTD.
    Date Cleared
    2000-11-22

    (33 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NARISHIGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003302
    Device Name
    IM-5A INJECTOR
    Manufacturer
    NARISHIGE CO., LTD.
    Date Cleared
    2000-11-22

    (33 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NARISHIGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003303
    Device Name
    IM-5B MICROINJECTOR
    Manufacturer
    NARISHIGE CO., LTD.
    Date Cleared
    2000-11-22

    (33 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NARISHIGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003304
    Device Name
    IM-6 MICROINJECTOR
    Manufacturer
    NARISHIGE CO., LTD.
    Date Cleared
    2000-11-22

    (33 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NARISHIGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003298
    Device Name
    MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
    Manufacturer
    NARISHIGE CO., LTD.
    Date Cleared
    2000-11-21

    (32 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NARISHIGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002850
    Device Name
    MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
    Manufacturer
    NARISHIGE CO., LTD.
    Date Cleared
    2000-10-05

    (22 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NARISHIGE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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