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

    Gems Vitrification Set, Gems Warming Set

    K Number: K162409 · Decision May 24, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    6
    Review Days
    268

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    Basic Information

    Device Name
    Gems Vitrification Set, Gems Warming Set
    K Number
    K162409
    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
    August 29, 2016
    Decision Date
    May 24, 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
    K180188 Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
    K180304 Geri Embryo Incubator and Geri Dish
    K171736 Geri Embryo Incubator and Geri Dish
    K170498 Gems Oocyte Retrieval Buffer ORB-20, ORB-50
    K161261 Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase