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510(k) Data Aggregation

    K Number
    K103375
    Device Name
    PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL
    Manufacturer
    MEDTEK DEVICES, INC.
    Date Cleared
    2011-03-16

    (120 days)

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

    MEDTEK DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PLUMEPEN is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Indications for use for PLUMEPEN® Integrated Smoke Evacuation Pencil include: - To remove smoke plume from the surgical site a. - b. To remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect
    Device Description
    The PLUMEPEN Integrated Smoke Evacuation Pencil is a sterile, single use integrated electrosurgical pencil and smoke evacuation handpiece. The device is intended for general electrosurgical applications and when used in conjunction with an effective smoke evacuation system, for removing smoke generated by electrosurgery. The device is constructed using the same materials and design specifications commonly found in the predicate devices in the electrosurgical marketplace. The device is designed to integrate smoke evacuation into electrosurgery by combining both features into a single handpiece. The integrated smoke evacuation pathway is located above the electrosurgical blade to capture the smoke plume created during cauterization. The extendable channel allows for adjustment of the capture position to accommodate a variety of different style and length electrosurgical blades. There are two (2) buttons on the device, which activate monopolar cut or coagulate. The pencil is connected to tubing which will be attached to a variety of smoke evacuation systems. The smoke is then filtered by the smoke evacuation system to limit personnel exposure to the hazards associated with surgical smoke plume. The device will be packaged singly for sterile distribution.
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    K Number
    K052797
    Device Name
    LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM
    Manufacturer
    MEDTEK DEVICES, INC.
    Date Cleared
    2006-02-13

    (133 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTEK DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to significantly improve visualization. LapEvac may be used in any laparoscopic surgery, as appropriate. Sterile, single use only device
    Device Description
    LapEvac is a battery operated smoke evacuation system that connects directly to the inlet and outlet cannula/ trocars and creates a continuous closed circuit for filtering pneumoperitoneum gaseous media (typically CO2). The system contains the LapEvac unit and connection tubing. Filtration is accomplished using activated charcoal filtration media and ULPA filtration media. The system filters and recirculates at an approximate rate of 4 liters per minute. Operating life is approximately 4 hours. A 3 amp, UL rated slide switch provides on/off control.
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