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

    MONA LISA ASPIRATION NEEDLE

    K Number: K032208 · Decision Dec 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    4
    Review Days
    144

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    Basic Information

    Device Name
    MONA LISA ASPIRATION NEEDLE
    K Number
    K032208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fertility Technology Resources, Inc.
    Date Received
    July 18, 2003
    Decision Date
    December 9, 2003
    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 Fertility Technology Resources, Inc.

    K Number Device Name
    K041470 MORTON IUI CATHETERS
    K023017 TUCKER EMBRYO CATHETER
    K992307 EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER