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

    Disposable Hemoclip (AF series)

    K Number: K231633 · Decision Jan 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    220

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    Basic Information

    Device Name
    Disposable Hemoclip (AF series)
    K Number
    K231633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alton (Shanghai) Medical Instruments Co., Ltd.
    Date Received
    June 5, 2023
    Decision Date
    January 11, 2024
    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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    K Number Device Name
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