BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)

    K Number: K161186 · Decision Jun 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    45
    Applicant Total
    39
    Review Days
    63

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    Basic Information

    Device Name
    Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
    K Number
    K161186
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Medical Systems U.S.A, Inc.
    Date Received
    April 27, 2016
    Decision Date
    June 29, 2016
    Product Code
    KGE
    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
    KGE Forceps, Biopsy, Electric

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