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

    Disposable Endoscopic Bipolar

    K Number: K231615 · Decision Dec 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    2
    Review Days
    186

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    Basic Information

    Device Name
    Disposable Endoscopic Bipolar
    K Number
    K231615
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Hope Biomedical Science & Technology Co., Ltd.
    Date Received
    June 2, 2023
    Decision Date
    December 5, 2023
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Jiangsu Hope Biomedical Science & Technology Co., Ltd.

    K Number Device Name
    K232703 Disposable Bipolar Forceps