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510(k) Data Aggregation

    K Number
    K130983
    Device Name
    GENII ARC SMART ARGON PROBE
    Manufacturer
    GENII, INC.
    Date Cleared
    2013-09-26

    (170 days)

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

    GENII, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ArC Smart™ Argon Probe is indicated for argon enhanced coagulation of tissue.
    Device Description
    The Genii ArC Smart™ Argon Probe is a flexible, single patient use catheter accessory which delivers argon gas and energy for non-contact coagulation therapy in conjunction with an argon equipped electrosurgery generator such as the Genii gi4000. It is intended for flexible endoscopic applications. The Genii ArC Smart™ Argon Probe consists of a hollow polytetrafluroethylene (PTFE) tube containing a stainless steel wire that extends from a probe connector to the distal end of the probe. The proximal end of the stainless steel wire is crimped into the connector body. The distal end of the wire is crimped to an electrode made of tungsten in a configuration specifically designed to enhance the ionization of argon gas as the gas passes through the open lumen of the PTFE tube. The electrode remains recessed in the PTFE tube such that there is no direct tissue contact during the electrosurgery procedure. The ArC Smart™ Probe is fabricated in several sizes (2.3mm to 3.2 mm outer diameters; 220 to 330cm lengths) to accommodate the various sizes of flexible endoscopes used by a physician performing various argon assisted coagulation procedures. The devices accommodate an argon flow rate of 0.1 to 2.0 liters per minute over all probe sizes. The clinical use maximum is 90 watts. The ArC Smart™ argon probes are shipped sterile in sealed Tyvek pouches and are single use only. Sterilization is by ethylene oxide.
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    K Number
    K113265
    Device Name
    GENII GI 4000 ELECTROSUGICAL GENERATOR
    Manufacturer
    GENII, INC.
    Date Cleared
    2012-03-22

    (139 days)

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

    GENII, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The gi 4000 Electrosurgery Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated lavage pump is intended to wash tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope water jet channels, or endoscope working channels. The Genii ArConnect™ Conducting Adapter is intended for use with the gi 4000 during argon assisted coagulation.
    Device Description
    The gi 4000 has seven monopolar outputs, a monopolar argon assisted coagulation output, and a bipolar output. Users make selections from a touch screen that displays stored default power setting start points, convenience and safety information, as well as indications as to current selection mode and return electrode monitoring status. The gi 4000 has an integrated peristatic lavage pump designed to provide lavage washing in the gut, either by accessories connected directly to endoscopes which have dedicated washing channels, or by accessories which introduce lavage fluid into the biopsy port of an endoscope or via dedicated washing channels incorporated into a therapeutic accessory such as a bipolar endostasis probe. The system is operated by a dual pedal footswitch which controls the lavage pump and power delivery. The argon output is designed for an argon assisted coagulation method. This method uses 99.99% pure argon gas to provide ionized RF arcs to the targeted tissue. The monopolar outputs are designed for cutting and coagulation methods. The unit is designed with a standard monopolar active cord receptacle (foot switch activated). Endoscopic accessories connect to the monopolar receptacle via a widely available detachable active cord accessory. Both the monopolar and argon outputs require the use of a patient return electrode (grounding pad) to return the RF energy from the patient back to the generator. The unit is designed with a standard GI bipolar single jack receptacle. No patient return electrode (grounding pad) is needed for bipolar methods. The output power of the argon, monopolar and bipolar methods are independently controlled through a touch panel LCD display located on the front panel of the generator. The argon gas for the argon output is exclusively supplied by the disposable Genii Argon Gas Canister. Each canister contains 49 liters of ultra-high purity (99.999% pure) argon gas (certified). When using the Argon Coagulation Method, the ArConnect is intended for single-use only and will be supplied as a non-sterile, disposable item. The ArConnect has been designed to allow the delivery of monopolar high frequency electrosurgical energy and argon gas to a single use argon coagulation probe sold separately. The ArConnect is supplied individually packaged in disposable packaging and is not to be reprocessed or re-used.
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