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510(k) Data Aggregation

    K Number
    K170112
    Device Name
    IMD's Lumbar Puncture Needle
    Manufacturer
    INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD)
    Date Cleared
    2018-02-02

    (386 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL MEDICAL DEVELOPMENT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMD's Lumbar Puncture Needle, a single patient use needle; it is intended to gain entry into or puncture the spinal cavity permitting injecting (including anesthesia) / withdrawl of fluids for purpose of diagnostic lumbar puncture, myelography discography procedures. The device is intended for adult and pediatric patients. It is to be used only under the direction of a licensed clinician.
    Device Description
    The IMD Inc. Lumbar Puncture Needle shares major similarities with the predicate device(s), in as much as the configuration, materials, area of use, and are identical to the IMD reference devices. It consists of an introducer, stylet, and pencil-point needle, with plastic hubs, and stainless steel cannula. Offered in 18-27 gauges, and 3.5 in. (90 mm) and 5.0 in (124 mm) lengths.
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    K Number
    K070354
    Device Name
    IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
    Manufacturer
    INTERNATIONAL MEDICAL DEVELOPMENT, INC
    Date Cleared
    2007-10-05

    (241 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL MEDICAL DEVELOPMENT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMD's specialty / anesthesia needles – Tuohy, Quincke and Pencil Point Needles – are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
    Device Description
    Anesthesia conduction needles consist of a luer hub, a stainless steel cannula with various tip types, and a stainless steel stylet. These needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needles fit into an introducer needle. This is a simple hypodermic needle to make the initial puncture through the skin to aid in the placement of the anesthesia conduction needle. The later can facilitate the placement of an epidural catheter for continuous infusion of local anesthetics into the epidural space for longer pain relief. The IMD anesthesia conduction needles - Tuohy, Quincke, and Pencil Point - are single use, sterile and latex-free medical devices for transient delivery of anesthetics during regional anesthesia. The cannula is stabilized during puncture with use of an inner stylet. This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for regional anesthesia. Then the anesthetics can be applied transiently (i.e., within minutes) by the professional anesthetist. Alternatively or additionally, an epidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.
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