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

    Bronchi and Gastrointestinal Cytology Brush

    K Number: K171607 · Decision Jul 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    43
    Applicant Total
    7
    Review Days
    60

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    Basic Information

    Device Name
    Bronchi and Gastrointestinal Cytology Brush
    K Number
    K171607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson-Cook Medical Inc./Cook Endoscopy
    Date Received
    June 1, 2017
    Decision Date
    July 31, 2017
    Product Code
    FDX
    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
    FDX Endoscopic Cytology Brush

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