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

    SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)

    K Number: K061394 · Decision Sep 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    31
    Review Days
    110

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    Basic Information

    Device Name
    SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
    K Number
    K061394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Busse Hospital Disposables, Inc.
    Date Received
    May 19, 2006
    Decision Date
    September 6, 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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    Other Clearances by Busse Hospital Disposables, Inc.

    K Number Device Name
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    K093909 BUSSE SURGICAL DRAPES IV
    K092212 BUSSE SURGICAL DRAPES III
    K082297 BUSSE SURGICAL DRAPE
    K073222 MODIFICATION TO:SPECIALTY NEEDLES
    K070465 BUSSE EPIDURAL CATHETER
    K063018 GLASS LOSS OF RESISTANCE SYRINGE
    K061570 I-STYLE BONE MARROW ASPIRATION NEEDLE
    K052843 BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
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    Search all 31 clearances from Busse Hospital Disposables, Inc. →