BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Cryotop US

    K Number: K153027 · Decision Mar 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    49
    Applicant Total
    5
    Review Days
    150

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    Basic Information

    Device Name
    Cryotop US
    K Number
    K153027
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kitazato Biopharma Co., Ltd.
    Date Received
    October 16, 2015
    Decision Date
    March 14, 2016
    Product Code
    MQK
    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
    MQK Labware, Assisted Reproduction

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    Other Clearances by Kitazato Biopharma Co., Ltd.

    K Number Device Name
    K160864 Cryotop Vitrification Kit and Cryotop Thawing Kit
    K160863 PBS(-), Phosphate Buffered Saline
    K160142 MINERAL OIL
    K140072 CRYOTOP(R) SC