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

    CANNULATED DRILL BIT

    K Number: K915692 · Decision Jan 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    560
    Registration Numbers
    560
    Same Product Code
    10
    Applicant Total
    163
    Review Days
    24

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    Basic Information

    Device Name
    CANNULATED DRILL BIT
    K Number
    K915692
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    December 23, 1991
    Decision Date
    January 16, 1992
    Product Code
    HTW
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HTW Bit, Drill

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