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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Rotatable Snares, Non-Rotatable Snares

    K Number: K172758 · Decision Mar 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    62
    Applicant Total
    13
    Review Days
    175

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    Basic Information

    Device Name
    Rotatable Snares, Non-Rotatable Snares
    K Number
    K172758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Chuangxiang Medical Technology Co., Ltd.
    Date Received
    September 13, 2017
    Decision Date
    March 7, 2018
    Product Code
    FDI
    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
    FDI Snare, Flexible

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