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

    RX EPIDURAL NEEDLE

    K Number: K053318 · Decision Feb 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    14
    Review Days
    79

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    Basic Information

    Device Name
    RX EPIDURAL NEEDLE
    K Number
    K053318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epimed International, Inc.
    Date Received
    November 30, 2005
    Decision Date
    February 17, 2006
    Product Code
    BSP
    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
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

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