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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPPENDORF AG

    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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