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

    SCOPE BUDDY PLUS Endoscope Flushing Aid

    K Number: K213833 · Decision Jan 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    57
    Applicant Total
    2
    Review Days
    36

    Basic Information

    Device Name
    SCOPE BUDDY PLUS Endoscope Flushing Aid
    K Number
    K213833
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medivators Inc
    Date Received
    December 9, 2021
    Decision Date
    January 14, 2022
    Product Code
    FEB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FEB Accessories, Cleaning, For Endoscope

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