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

    EPIDURAL NEEDLE

    K Number: K942863 · Decision Aug 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    8
    Review Days
    420

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    Basic Information

    Device Name
    EPIDURAL NEEDLE
    K Number
    K942863
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Spinal Specialties, Inc.
    Date Received
    June 17, 1994
    Decision Date
    August 11, 1995
    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 Spinal Specialties, Inc.

    K Number Device Name
    K960100 SPINAL SPECIALTIES NERVE BLOCK TRAY
    K960082 DISCOGRAPHY KIT
    K950820 SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE
    K943319 GERTIE MARX EPI-SPINAL TRAY
    K944029 CONTINUOUS EPIDURAL ANESTHESIA TRAY
    K941343 SPINAL ANESTHESIA TRAY
    K935245 EPIDURAL ANESTHESIA TRAY