BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AUXILIARY INSTRUMENTS FOR URS

    K Number: K971315 · Decision Sep 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    188
    Registration Numbers
    188
    Same Product Code
    38
    Applicant Total
    142
    Review Days
    159

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    Basic Information

    Device Name
    AUXILIARY INSTRUMENTS FOR URS
    K Number
    K971315
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    April 9, 1997
    Decision Date
    September 15, 1997
    Product Code
    FCL
    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
    FCL Forceps, Biopsy, Non-Electric

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