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

    Kitazato ET Catheters

    K Number: K192540 · Decision May 1, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    52
    Applicant Total
    13
    Review Days
    228

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    Basic Information

    Device Name
    Kitazato ET Catheters
    K Number
    K192540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6110
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kitazato Corporation
    Date Received
    September 16, 2019
    Decision Date
    May 1, 2020
    Product Code
    MQF
    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
    MQF Catheter, Assisted Reproduction

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    Other Clearances by Kitazato Corporation

    K Number Device Name
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    K193522 iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
    K192845 Sperm Freeze, Sperm Fridge
    K190199 SepaSperm Washing Solution, SepaSperm Solution
    K181469 Cryotop®US-flash and Cryotop®US-scoop
    K182002 Cumulus Remover
    K171748 Vitrification Kit and Thawing Kit
    K162878 Kitazato ET Catheters
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