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

    Single Use Ureteral Access Sheath

    K Number: K220065 · Decision May 25, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    13
    Review Days
    135

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    Basic Information

    Device Name
    Single Use Ureteral Access Sheath
    K Number
    K220065
    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
    January 10, 2022
    Decision Date
    May 25, 2022
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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

    K Number Device Name
    K253132 Single use stone retrieval balloons
    K251890 Disposable Ureteral Stents
    K230773 Endoscopy Irrigation Tubing
    K231471 Air/Water Bottle Tubing, CO2 Source Tubing
    K220063 Single Use Cytology Brush
    K212669 Single Use Hemoclip
    K212668 Sclerotherapy Needle
    K191900 Single Use Grasping Forceps
    K192258 Disposable Valve Sets
    K173758 Disposable Biopsy Valve
    Search all 13 clearances from Zhejiang Chuangxiang Medical Technology Co., Ltd. →