BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KITAZATO OPU NEEDLE

    K Number: K112462 · Decision Nov 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    3
    Review Days
    458

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    Basic Information

    Device Name
    KITAZATO OPU NEEDLE
    K Number
    K112462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kitazato Medical Co., Ltd.
    Date Received
    August 26, 2011
    Decision Date
    November 26, 2012
    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 Kitazato Medical Co., Ltd.

    K Number Device Name
    K131491 KITAZATO IUI CATHETER
    K112396 IUI CATHETERS