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

    ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT

    K Number: K121604 · Decision Jul 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
    K Number
    K121604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Obp Corporation
    Date Received
    June 1, 2012
    Decision Date
    July 27, 2012
    Product Code
    FER
    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
    FER Anoscope And Accessories

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