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

    Single Use Rotatable and Repositionable Hemoclip

    K Number: K201771 · Decision Oct 19, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    112

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    Basic Information

    Device Name
    Single Use Rotatable and Repositionable Hemoclip
    K Number
    K201771
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anrei Medical (Hangzhou) Co., Ltd.
    Date Received
    June 29, 2020
    Decision Date
    October 19, 2020
    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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