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510(k) Data Aggregation

    K Number
    K142207
    Device Name
    TransferMan 4m Micromanipulator
    Manufacturer
    EPPENDORF AG
    Date Cleared
    2015-01-23

    (165 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TransferMan® 4m Micromanipulator Indications for Use: The TransferMan® 4m Micromanipulator is intended for use in assisted reproduction procedures requiring coarse and fine positioning of a microtool under the microscope. CellTram® Air Microinjector / CellTram® Oil Microinjector / CellTrans® vario Microinjector Indications for Use: The CellTram® Microinjectors are intended for use in Intra-Cytoplasmic Spermatozoa Injection (ICSI) procedures to aspirate and inject sperm into oocytes.
    Device Description
    The TransferMan® 4m Micromanipulator is a motorized micromanipulator consisting of a Motor module unit and a Control board that allows the user to precisely control the movement of tools (i.e., microcapillaries) used for Intra-Cytoplasmic Spermatozoa Injection (ICSI) and other In Vitro Fertilization (IVF) procedures. The tool is mounted in a Universal Capillary Holder on the TransferMan® 4m Micromanipulator's Motor module unit that is, itself, mounted to an inverted microscope. The user controls the movements of the tool using a joystick on the Control board. The Motor module unit shifts the position of the tool in response to the joystick motions. The CellTram Microinjectors are manual piston pumps for holding and transfer of suspension cells (e.g., oocytes and sperms for use in ICSI procedures), used in manual microinjection procedures. Using a movable piston in a cylinder system, the CellTram® Microinjectors generate differences in pressure that are transferred directly to a microcapillary via a connected pressure tube. Depending on the piston movement, material can be aspirated or dispensed. Three versions of the CellTram® Microinjectors will be marketed for use in ICSI procedures, the CellTram® Air, the CellTram® Oil, and the CellTram vario. The three versions differ in the medium used for pressure transmission (air versus oil).
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    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
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    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
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    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
    K993884
    Device Name
    GENX MICROTOOLS
    Manufacturer
    <GENX> INTL., INC.
    Date Cleared
    2000-02-14

    (90 days)

    Product Code
    MQJ
    Regulation Number
    884.6150
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to micromanipulate, hold, or transfer gametes or embryos for assisted hatching, intsacytoplasmic sperm injection (ICSI) or other assisted reproduction methods
    Device Description
    The basic design is a borosilicate glass tube, drawn to form a microinjection and/or microholding holding instrument. Each is angled towards the tip end to allow the instrument to be parallel to the surface of the dish. By apply suction the holding pipette is able to hold the cell in place, and the micro injection tool may pull cells into the hollow middle and then inject these cells into a larger cell mass.
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