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

    SPINAL EPIDURAL NEEDLES

    K Number: K002405 · Decision Jun 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    5
    Review Days
    298

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    Basic Information

    Device Name
    SPINAL EPIDURAL NEEDLES
    K Number
    K002405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Te ME NA S.A.R.L.
    Date Received
    August 7, 2000
    Decision Date
    June 1, 2001
    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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    Other Clearances by Te ME NA S.A.R.L.

    K Number Device Name
    K990323 TE ME NA POLYSTIM NERVE STIMILATOR
    K991259 TE ME NA EPIDURAL CATHETER
    K990100 POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
    K990020 TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC