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

    ThinkMed Intermittent Catheter with/without Hydrophilic Coating

    K Number: K142767 · Decision Feb 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    2
    Review Days
    131

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    Basic Information

    Device Name
    ThinkMed Intermittent Catheter with/without Hydrophilic Coating
    K Number
    K142767
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thinkmed Medical Technology Co., Ltd.
    Date Received
    September 25, 2014
    Decision Date
    February 3, 2015
    Product Code
    GBM
    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
    GBM Catheter, Urethral

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    Other Clearances by Thinkmed Medical Technology Co., Ltd.

    K Number Device Name
    K142765 TM SAFETY NEEDLE