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

    Hemospray Endoscopic Hemostat

    K Number: DEN170015 · Decision May 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    10
    Applicant Total
    125
    Review Days
    424

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    Basic Information

    Device Name
    Hemospray Endoscopic Hemostat
    K Number
    DEN170015
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4456
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Wilson-Cook Medical, Inc.
    Date Received
    March 9, 2017
    Decision Date
    May 7, 2018
    Product Code
    QAU
    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
    QAU Hemostatic Device For Endoscopic Gastrointestinal Use

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