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

    LAURIMED SPINAL INJECTION SYSTEM

    K Number: K080140 · Decision May 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    8
    Review Days
    108

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    Basic Information

    Device Name
    LAURIMED SPINAL INJECTION SYSTEM
    K Number
    K080140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laurimed, LLC
    Date Received
    January 22, 2008
    Decision Date
    May 9, 2008
    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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    K091818 LAURIMED SPINAL INJECTION SYSTEM
    K090815 PERCUTANEOUS DISCECTOMY SYSTEM
    K083909 SPINAL INJECTION SYSTEM
    K082194 LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002