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

    XBO1-824-18/19/20 BIOPSY FORCEPS

    K Number: K012074 · Decision Sep 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    73
    Applicant Total
    22
    Review Days
    85

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    Basic Information

    Device Name
    XBO1-824-18/19/20 BIOPSY FORCEPS
    K Number
    K012074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Olympus Optical Co.
    Date Received
    July 2, 2001
    Decision Date
    September 25, 2001
    Product Code
    OCZ
    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
    OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

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