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

    Towako Transmyometrial Embryo Transfer Set

    K Number: K173431 · Decision May 18, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    52
    Applicant Total
    14
    Review Days
    197

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    Basic Information

    Device Name
    Towako Transmyometrial Embryo Transfer Set
    K Number
    K173431
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.6110
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    William A. Cook Australia Pty. , Ltd.
    Date Received
    November 2, 2017
    Decision Date
    May 18, 2018
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MQF), ordered by most recent decision date.

    Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)

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    Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators

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