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

    Disposable Valve Sets

    K Number: K192258 · Decision Dec 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    71
    Applicant Total
    13
    Review Days
    132

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    Basic Information

    Device Name
    Disposable Valve Sets
    K Number
    K192258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Chuangxiang Medical Technology Co., Ltd.
    Date Received
    August 20, 2019
    Decision Date
    December 30, 2019
    Product Code
    ODC
    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
    ODC Endoscope Channel Accessory

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    Other Clearances by Zhejiang Chuangxiang Medical Technology Co., Ltd.

    K Number Device Name
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    K220063 Single Use Cytology Brush
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    K220065 Single Use Ureteral Access Sheath
    K212668 Sclerotherapy Needle
    K191900 Single Use Grasping Forceps
    K173758 Disposable Biopsy Valve
    Search all 13 clearances from Zhejiang Chuangxiang Medical Technology Co., Ltd. →