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510(k) Data Aggregation

    K Number
    K170721
    Device Name
    Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil
    Date Cleared
    2017-04-21

    (43 days)

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

    Precision Surgical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cut-Vac® Smoke Evacuation Electrosurgical is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgical current when used in conjunction with an effective smoke evacuation system. This device conducts an electrosurgical current from an electrosurgical generator and delivers it to the target tissue to achieve the desired surgical effect.
    Device Description
    The Precision Surgical Cut-Vac® Lighted Smoke Evacuation Electrosurgical Pencil is a standard monopolar electrosurgical pencil with incorporated LED light, and suction ability for cautery smoke. It is a sterile single use device. It performs all standard functions of an electrosurgical pencil with separate buttons for Cutting and Coagulation. Cut-Vac connects to all standard electrosurgical generator units with a standard 3-prong plug. The Cut and Coag buttons, and light switch are on the top of the device. The proximal button to the tip/blade is yellow and controls Cutting. The blue button distal to the tip controls Coagulation. The green slider switch turns the LED light on and off. The LED light does not interfere with the function of the pencil and is encased in clear thermoplastic and does not contact liquid. The light allows the operator to visualize areas during surgeries or overcome shadows despite surgical Operating Room lights. It has removable separate small batteries that are located in the distal plug that attaches to the ESP, and thus are disposable in an environmentally safe method. The retractable blade allows the operator to better control smoke evacuation by shortening the effective blade length. Cut-Vac does not have irrigation capability. It has an 8.5 foot suction tube to attach to any suction with an additional 5 feet of electro-surgical cable from the end of the suction tube to attach to an ESP generator. The first 8.5 feet of the suction tube incorporates the electro-surgical cable to eliminate clutter on the surgical field. The electrical-surgical cable leaves the tubing through a sealed and molded closed port and terminates in a standard 3-prong electro-surgical plug. The remaining portion of the suction tubing terminates to a flexible connector that attaches to different suction canister ports. The integrated device enables the operator to cut, coagulate, evacuate smoke and illuminate the surgical site without the need for separate tools. The Cut-Vac® device must be used in conjunction with an electrosurgical generator and grounding pads in order to power up the device.
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