BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇨 Monaco

    Bi-Flex Evo

    K Number: K182144 · Decision Sep 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    Bi-Flex Evo
    K Number
    K182144
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promepla Sam
    Date Received
    August 8, 2018
    Decision Date
    September 7, 2018
    Product Code
    KNY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNY Accessories, Catheter, G-U

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