BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Single Lumen Ovum Aspiration Needles

    K Number: K171625 · Decision Jan 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    2
    Review Days
    224

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    Basic Information

    Device Name
    Single Lumen Ovum Aspiration Needles
    K Number
    K171625
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.6100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Willian A. Cook Australia Pty, Ltd.
    Date Received
    June 2, 2017
    Decision Date
    January 12, 2018
    Product Code
    MQE
    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
    MQE Needle, Assisted Reproduction

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    Other Clearances by Willian A. Cook Australia Pty, Ltd.

    K Number Device Name
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