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

    Sclerotherapy Needle

    K Number: K212668 · Decision Feb 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    88
    Applicant Total
    13
    Review Days
    184

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    Basic Information

    Device Name
    Sclerotherapy Needle
    K Number
    K212668
    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 23, 2021
    Decision Date
    February 23, 2022
    Product Code
    FBK
    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
    FBK Endoscopic Injection Needle, 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
    K220065 Single Use Ureteral Access Sheath
    K191900 Single Use Grasping Forceps
    K192258 Disposable Valve Sets
    K173758 Disposable Biopsy Valve
    Search all 13 clearances from Zhejiang Chuangxiang Medical Technology Co., Ltd. →