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510(k) Data Aggregation

    K Number
    K120475
    Device Name
    ANESTHESIA CONDUCTION NEEDLES
    Date Cleared
    2012-12-21

    (309 days)

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

    **SHANGHAI SA MEDICAL **& PLASTIC INSTRUMENTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Anesthesia conduction needles are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
    Device Description
    needles, including Epidural Needle for Single Use(AN-E), Spinal Needle for Single Use(AN-S), AN-SII), consist of needle tube, hub, stylet and jacket The product is mainly used for epidural and/or spinal block (also called as epidural and/or spinal anesthesia) in human bodies. The needles have been categorized as following in detail: 1. AN-SI Spinal Needles (same to IMD's Quincke needle) 2. AN-SII Spinal Needle (same to IMD's Pencil point needle) 3. AN-E Epidural Needles (same to IMD's Tuchy needle) These needles are provided as sterile, single use devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needle. This is a simple hypodernic regional allestilesia trays (Mis). Anoonball concession of the aresthesia onduction needle. The later needie to hake the intral punction and election of local and the end anesthelics into the epidural space for longer pain relief. The Shanghai SA's anesthesia conduction needles – AN-SI, AN-SII, AN-SII, AN-E – are single use, sterile madical devices for like The Shanghal SA s anesulesia conductions. The cannula is stabilized during puncture with use of an Inner thanslent delively of ancollobo acting regioned its reached its analogical site for regional style. This stylet is within atter the ansociety (i.e., within minutes) by the professional ansether and the possible. The altestiesia. Then the arestheses our as opplied below the anesthesia conduction needle. The needle is Allondavely of dealer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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