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

    Single Use Hemoclip

    K Number: K212669 · Decision May 27, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    62
    Applicant Total
    13
    Review Days
    277

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    Basic Information

    Device Name
    Single Use Hemoclip
    K Number
    K212669
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    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
    May 27, 2022
    Product Code
    PKL
    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
    PKL Hemostatic Metal Clip For The Gi Tract

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