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

    Disposable Linear Stapler, Disposable Linear Cutter

    K Number: K172538 · Decision Nov 30, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    168
    Same Product Code
    279
    Applicant Total
    1
    Review Days
    100

    Basic Information

    Device Name
    Disposable Linear Stapler, Disposable Linear Cutter
    K Number
    K172538
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4750
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Changzhou Kangdi Medical Stapler Co.,Ltd.
    Date Received
    August 22, 2017
    Decision Date
    November 30, 2017
    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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