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

    easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use

    K Number: K210909 · Decision Jun 24, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    168
    Same Product Code
    279
    Applicant Total
    4
    Review Days
    87

    Basic Information

    Device Name
    easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
    K Number
    K210909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ezisurg Medical Co., Ltd.
    Date Received
    March 29, 2021
    Decision Date
    June 24, 2021
    Product Code
    GDW
    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
    GDW Staple, Implantable

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    Other Clearances by Ezisurg Medical Co., Ltd.

    K Number Device Name
    K183477 easyPPHTM Hemorrhoidal Stapler for Single Use
    K181657 easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
    K172960 easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use