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

    Bio Guard Air/Water & Suction Valves

    K Number: K192059 · Decision Sep 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    71
    Applicant Total
    94
    Review Days
    47

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    Basic Information

    Device Name
    Bio Guard Air/Water & Suction Valves
    K Number
    K192059
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    United States Endoscopy Group, Inc.
    Date Received
    August 1, 2019
    Decision Date
    September 17, 2019
    Product Code
    ODC
    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
    ODC Endoscope Channel Accessory

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