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510(k) Data Aggregation

    K Number
    K080197
    Device Name
    PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
    Manufacturer
    PLASMA SURGICAL, LTD.
    Date Cleared
    2008-06-24

    (151 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLASMA SURGICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K030819
    Device Name
    PLASMAJET SYSTEM
    Manufacturer
    PLASMA SURGICAL, LTD.
    Date Cleared
    2004-08-05

    (510 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLASMA SURGICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PlasmaJet™ System is a neutral plasma coagulator that is designed for coagulation in open surgery and laparoscopic surgery.
    Device Description
    The PlasmaJet™ system consists of a range of single-use open or laparoscopic handpieces that are assured for obagains. A console is used to power the handpiece and a footswitch and a service module (providing a used to power the handplose for an argon tank) completes the system. In the PlasmaJet™ system, as in a bipolar electrosurgery system, both anode and cathode used to generate the argon partic no ground plate is used. "Decated bour the patient and no more of alternate the liandpiece there is no carrent no niece, a specially designed series of electrodes and allows a relatively low voltage (of about 30V) to generate a more energetic and allows a relatively 101. PlasmaJet™ plasma uses a much lower flow of argon gas than is used in the argon I lasmarco - plasma ases a mis electrically neutral and comprises a mixture of excited Deall Coagulator, the plasma is crocere....) argon atoms, argon ions, and electrons that emerge from the tip of the handpiece in an intense pale blue jet or beam. When the plasma jet reaches the bleeding tissue, it gives up its kinctic energy as heat which the plasma fer reasies in the bleeding surface by a series of processes. First, the allu causes coaganacon of the broom of argon plasma removes liquid blood from the tissue surface or vessel. Secondly, the energy dissipated from the plasma to the tissue ussuc surface of recom of corm a series of layers of eschar that seal the tissue surface and prevent further bleeding.
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