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

    RIWO SYSTEM TRAYS

    K Number: K012309 · Decision Oct 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    56
    Applicant Total
    142
    Review Days
    88

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    Basic Information

    Device Name
    RIWO SYSTEM TRAYS
    K Number
    K012309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    July 23, 2001
    Decision Date
    October 19, 2001
    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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