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

    ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set

    K Number: K143164 · Decision Dec 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    11
    Review Days
    29

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    Basic Information

    Device Name
    ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
    K Number
    K143164
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kimberly-Clark Corporation
    Date Received
    November 3, 2014
    Decision Date
    December 2, 2014
    Product Code
    BSO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSO Catheter, Conduction, Anesthetic

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