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510(k) Data Aggregation

    K Number
    K113500
    Device Name
    CANADY VIEIRA HYBRID PLASMA SCALPEL
    Manufacturer
    US MEDICAL INNOVATIONS LLC
    Date Cleared
    2011-12-09

    (14 days)

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

    US MEDICAL INNOVATIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hybrid Plasma Scalpel provides cutting and gas coagulation during open surgical procedure where monopolar electrosurgery (cutting and coagulation) is normally used. The Hybrid Plasma Scalpel is a monopolar handpiece used with compatible electrosurgical units.
    Device Description
    The Canady Vieira Hybrid Plasma™ Scalpel is an accessory multi-functional electrosurgical handpiece used for open surgical procedures where monopolar radio frequency electrosurgical handpieces (cutting, coagulation) is normally used. The handpiece uses radio frequency (RF) monopolar electrosurgical current to cut or coagulate biological tissue. The handpiece can also combine argon gas with radio frequency monopolar cut or coagulation currents to produce a hybrid plasma cut, or argon plasma coagulation. The handpiece consists of three major components: Handle, Telescoping Nozzle, and Electrode. The insulated handle encases the radio frequency (RF) current and gas tubing for controlling the flow of argon gas and activation of RF current for the device. RF current is activated by two push buttons yellow (standard CUT mode) and blue (standard COAG mode) which are top of the handle. Argon gas is delivered via the handle by activating a third push button (purple) which is also on top of the handle. The electrode tip has 4 modes of operation and as shown in the below table, this words appear depending on the mode of operation that is necessary. Depending on the RF current mode (CUT or COAG), the handpiece can function in the following argon modes: HYBRID PLASMA CUT – Argon gas is delivered through the handpiece while the attached electrosurgical generator is set in the CUT mode. Hybrid Argon Plasma Cut mode will cut and coagulate the tissue at the same time. ARGON PLASMA COAGULATION – Argon gas is delivered through the handpiece while the attached electrosurgical generator is set in the COAG mode. Argon Plasma Coagulation will coagulate the tissue. The Canady Vieira Hybrid Plasma™ Scalpel is an accessory that is used with the Argon 2 (CPC2) and Argon 4 (CPC4) generators, previously cleared by FDA. These generators provide a controlled flow of argon to the electrosurgical handpiece during Hybrid Plasma Cutting or Argon Plasma Coagulation modes. The Physician manually sets the flow rate on the Plasma coagulator. The telescoping nozzle can be extended or shortened over the electrode as desired when the surgeon is performing argon procedures.
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    K Number
    K100669
    Device Name
    CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES
    Manufacturer
    US MEDICAL INNOVATIONS LLC
    Date Cleared
    2011-04-06

    (393 days)

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

    US MEDICAL INNOVATIONS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Canady Plasma Coagulator devices are intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma Coagulator devices are Argon Plasma Coagulation Unit designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit models and compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes.
    Device Description
    The Canady Plasma"M Electrosurgical Unit Series with Accessories is an High Frequency (HF) Electrosurgery Unit (ESU) used in combination with Canady Plasma™ Coagulators (Argon 2 and Argon 4) gas units and probes (Canady Plasma™ GIT probe and Canady Plasma™ TBS probe). The Canady Plasma (ESU) series combines (HF) voltage to electrically enhanced plasma gas (i.e. Argon) to produce a plasma gas stream. Current density upon arrival at the tissue surface from Canady Plasma Probes causes coagulation of the tissue. Canady Plasma (ESU) series is also a monopolar and bipolar RF surgical device for cutting and coagulation. It is used for tissue removal and coagulation in accordance with the operative procedure performed by the physician. The unit provides various cutting and coagulation modes to meet the physician flexibility performing the specific procedure with the device. The Canady Plasma Electrosurgery Unit Model SS-200E is to only be used with the Canady Plasma Coagulator Argon 2. The Canady Plasma Electrosurgery Unit Model SS-601 Mca is to only be used with the Canady Plasma Coagulator Argon 4.
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