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

    MOTOR-DRIVE MANIPULATOR MM-89

    K Number: K002291 · Decision Sep 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    22
    Applicant Total
    20
    Review Days
    48

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MOTOR-DRIVE MANIPULATOR MM-89
    K Number
    K002291
    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
    July 27, 2000
    Decision Date
    September 13, 2000
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MQJ), ordered by most recent decision date.

    TransferMan 4m Micromanipulator

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MICROMANIPULATOR SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IM-11 PNEUMATIC MICROINJECTOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MM-87 MOTOR-DRIVE MANIPULATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MN-4 COARSE MANIPULATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IM-6 MICROINJECTOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Narishige Co., Ltd.

    K Number Device Name
    K120877 MICROMANIPULATOR SET
    K113712 IM-11 PNEUMATIC MICROINJECTOR
    K011420 MM-87 MOTOR-DRIVE MANIPULATOR
    K010298 MN-4 COARSE MANIPULATOR
    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
    Search all 20 clearances from Narishige Co., Ltd. →