BEUDAMED
    Product Code: MQJ FDA class 2 21 CFR 884.6150

    Micromanipulators And Microinjectors, Assisted Reproduction

    Obstetrics/Gynecology

    Micromanipulators and Microinjectors for Assisted Reproduction are obstetrics/gynecology devices used to precisely position and manipulate microtools under a microscope during ART procedures such as ICSI, enabling controlled injection of sperm into oocytes. Classified as FDA Class 2 under 21 CFR 884.6150, these are 510(k)-exempt and subject only to general controls. The product code is MQJ.

    View on FDA
    510(k)s
    23
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    4
    Years Active
    15

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    Basic Information

    Product Code
    MQJ
    Device Class
    FDA class 2
    Regulation Number
    884.6150
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 23 510(k) clearances via K numbers.

    K Number Device Name
    K142207 TransferMan 4m Micromanipulator
    K120877 MICROMANIPULATOR SET
    K113712 IM-11 PNEUMATIC MICROINJECTOR
    K011420 MM-87 MOTOR-DRIVE MANIPULATOR
    K010298 MN-4 COARSE MANIPULATOR
    K003304 IM-6 MICROINJECTOR
    K003303 IM-5B MICROINJECTOR
    K003302 IM-5A INJECTOR
    K003300 MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
    K003142 MICROMANIPULATOR
    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
    K002658 MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR
    K002653 MMN-1 COARSE MANIPULATOR
    K002293 3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
    K002291 MOTOR-DRIVE MANIPULATOR MM-89
    K001912 IM-9B MICROINJECTORS
    K001911 IM-9A MICROINJECTORS
    K001910 IM-9C MICROINJECTORS
    K001131 3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
    K001130 3D MANUAL COARSE MANIPULATOR MN-188NE
    K993884 GENX MICROTOOLS

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.