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

    ScopeSeal Duodenoscope Protective Device

    K Number: K183171 · Decision Oct 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    326

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    Basic Information

    Device Name
    ScopeSeal Duodenoscope Protective Device
    K Number
    K183171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gi Scientific, LLC
    Date Received
    November 16, 2018
    Decision Date
    October 8, 2019
    Product Code
    ODB
    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
    ODB Endoscopic Contamination Prevention Sheath

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