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

    Gems Oocyte Retrieval Buffer ORB-20, ORB-50

    K Number: K170498 · Decision Sep 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    6
    Review Days
    223

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    Basic Information

    Device Name
    Gems Oocyte Retrieval Buffer ORB-20, ORB-50
    K Number
    K170498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genea Biomedx Pty, Ltd.
    Date Received
    February 17, 2017
    Decision Date
    September 28, 2017
    Product Code
    MQL
    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
    MQL Media, Reproductive

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    Other Clearances by Genea Biomedx Pty, Ltd.

    K Number Device Name
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    K180304 Geri Embryo Incubator and Geri Dish
    K171736 Geri Embryo Incubator and Geri Dish
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