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

    DSNARE, MODEL 00711087

    K Number: K051637 · Decision Oct 31, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    94
    Review Days
    133

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    Basic Information

    Device Name
    DSNARE, MODEL 00711087
    K Number
    K051637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    United States Endoscopy Group, Inc.
    Date Received
    June 20, 2005
    Decision Date
    October 31, 2005
    Product Code
    FCK
    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
    FCK Instrument, Biopsy, Suction

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