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SafeAir Smoke Pencil. 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.

The SafeAir Smoke Pencil is a sterile single use integrated electrosurgical pencil and smoke evacuation handpiece. The device is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The integration of the electrosurgical pencil and smoke evacuation enables the operator to activate an electrosurgical current as well as capture the smoke plume simultaneously. The device is constructed of similar materials and design specifications as the predicate electrosurgical devices. The SafeAir Smoke Pencil combines the functions of electrosurgery and smoke evacuation into a single handpiece. The smoke evacuation orifice is located less than 1 cm from the electrosurgical blade to provide optimal smoke removal during cauterization. The smoke evacuation suction sleeve is adjustable to optimize the distance to the tip of the electrosurgical blade. As with the predicate GoldVac, the SafeAir Smoke Pencil is available in two (2) activation switch configurations, a rocker style and a push button style, which activate monopolar cut or coagulate functions. The device is connected to tubing using a dual connector to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to the surgical smoke plume. The device will be packaged singly for sterile distribution.