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This device is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

The device is intended to be used as a 24-month reusable patient return electrode for patients age 12 years and older. The Universal (model 0845) and Universal Plus (model 0847) have a single cord that connects to one generator. The Universal Dual (model 0846) and Universal Plus Dual (model 0848) have two cords that can connect to one or two generators. The Mega Soft Universal Patient Return Electrodes (ie. Mega Soft) are constructed of a layer of conductive material strain-relieved between an insulative polymer gel, and sealed between two layers of a thermal polyurethane plastic film. The thermal polyurethane plastic film and the contained polymer gel enveloping the conductive material is compressable but does not laterally move under pressure. The polymer acts as a dielectric protection and is encapsulated by a layer of urethane film. The dielectric protection remains between the thermal polyurethane plastic film and the conductive layer irrespective of pressure. A two-conductor cable connects the conductive layer of the device to a two-conductor DetachaCable™. The DetachaCable is connected to a standard monopolar ESU. The DetachaCable is available in a variety of configurations and lengths, designed to be compatible with the various compatible generators available on the market and was cleared under K080741 on 16 December 2008.

The Ethicon Megadyne Electrosurgical Generator (ESU) is intended as a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

The Ethicon Megadyne TM Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.

The Megadyne Smoke Evacuator with accessories is intended to remove smoke created in surgical procedures at the surgical site.

The Megadyne Smoke Evacuator is designed to provide smoke evacuation in open and Laparoscopic procedures for the removal of surgical smoke. Using a scroll pump and 4 stages of filtration, the Megadyne Smoke Evacuator is designed to evacuate surgical smoke both quietly and effectively. An intuitive front panel design allows users to customize both the rate of suction FLOW and the length of RUN TIME after the active electrode is deactivated. Push button selections for OPEN, LAP (laparoscopic), and MANUAL modes are also clearly marked and easily accessible. The Megadyne smoke evacuator provides evacuation of smoke plume via a smoke evacuation device and tubing (e.g. E-Z Clear Smoke Evacuation Electrosurgical Pencil under K141587 on February 18, 2015) connected to the face of the Filter.

The Ethicon Megadyne® Electrosurgical Generator is intended as a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

The Ethicon Megadyne Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.

The Megadyne Foot Switch is an accessory that is interface with compatible smoke evacuation systems to control on/off inputs for manual operation.

The Megadyne Foot Switch is used with a compatible smoke evaluation system to control on/off inputs for manual operation.

The ZIP PEN Smoke Evacuation Electrosurgical Pencil is a monopolar device 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. This device conducts an electrosurgical current from an electrosurgical generator and delivers it to the target tissue to achieve the desired surgical effect.

The ZIP Pen Smoke Evacuation Electrosurgical Pencil is a sterile, single use hand held electrosurgical pencil and smoke evacuation handpiece. It is a monopolar device 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 device consists of a printed circuit board, flexible electrical cable, dome switches, button switch mechanisms and sealing materials. The circuit board and electrical cable provide the means for powering the device. The dome switches operate the Cut and Coag functions. These components are enclosed within an upper housing and lower molded carriage and nozzle. which snap together. The buttons sit on top of the dome switches and extend through the upper housing and facilitate activation of the device. The button proximal to the electrode is yellow and controls the cut function of the device. The button distal to the electrode is blue and controls the coagulate function of the device. Within the nozzle, there is a metal collett that holds the electrode in place. The housing and other components are designed and assembled to prevent liquid from entering the electrical connections (preventing an electrical short). This is accomplished by over molding the circuit board with nonconductive materials. Clear tubing connects to the nozzle and provides a path for capturing electrosuraical smoke. The electro-surgical cable leaves the tubing through an open port and terminates at a 3-prong electro-surgical plug. The remaining portion of the tubing (without cable inside) terminates at a connector that attaches to the smoke evacuation filter. The connector is attached to the tubing and is included as part of the smoke evacuation pencil for connection to the filter. The ZIP Pen Smoke Evacuation Electrosurgical Pencil is available with 10 ft. and 15 ft. cord/tubing (catalog numbers 2525-10 and 2525-15, respectively) and is supplied with two additional items: A holster, which is used to hold the device when it is not in use during the procedure. The holster is a component of the device and will not be sold separately. A 2.5 inch Megadyne E-Z Clean electrode. The electrode is a separate, currently marketed device that received clearance in 2008 via K081791. The associated accessories include: Nozzle Extension can be used in electrosurgery procedures where a longer electrode is required to extend the smoke capture nozzle to the surgical site. Filter -- the ULPA and charcoal filters can be used with smoke evacuation units. They filter surgical smoke and odors removed from the surgical site. Adapter can be used to facilitate the tubing connection to a variety of smoke evacuation filter/units on the market.

This device is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

The MegaSoft Universal Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two symmetric layers of a viscoelastic polymer called Akton® The Akton polymer is encapsulated by a layer of urethane film. One twoconductor cable connects the conductive layer of the device to a two conductor DetachaCable . The DetachaCable is connected to a standard monopolar electrosurgical unit (ESU). The device cable is insulated, strain-relieved, and connected well inside the device to prevent patient or user burns. In use, this device will lay on the operating surface with the patient lying on either side of the pad. The pad size is approximately 36" x 20" x 0.135" and is intended for patients weighing ≥ 0.8 lb (350 grams).

This device is designed to be used whenever monopolar electrosurgy is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators. At the same time the product reduces the risk of pressure related injury due to immobility during surgery. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

The Mega Soft Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric lavers of a viscoelastic polymer called Akton . (The top layer of polymer is thinner than the bottom layer.) The Akton polymer is encapsulated by a layer of urethane film. One or two two-conductor cables connects the conductive layer of the device to a two conductor DetachaCable". The DetachaCable is connected to a standard monopolar electrosurgical unit (ESU). The device cable is insulated, strain-relieved, and connected well inside the device to prevent patient or user burns. In use, this device will lay on the operating surface with the patient lying on top, on the side labeled "patient side". The adult-size device is large enough to extend at least the length and width of a typical patient torso. Pad size is approximately 20" x 46" x 1/2". The pediatricsize device is approximately 12" x 26" x 1/2" and is intended for pediatric patients weighing between 0.8 and 50 lbs.

E-Z Clean electrosurgical electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization. Some tip configurations have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the generator's Advanced Cutting Effect (ACE) mode.

The Megadyne E-Z Clean electrosurgical electrode is a monopolar electrosurgical electrode that is coated with polytetrafluoroethylene (PTFE). It is insulated over the majority of its exposed length. It is intended for general electrosurgical use, and is designed to fit into and work in conjunction with an industry standard hand- or footactivated electrosurgical pencil which is connected to an electrosurgical unit or ESU. This device is supplied sterile and is not intended to be reused. The E-Z Clean electrosurgical electrodes are available in a number of tip configurations and lengths. Tips such as standard blades, modified blades, needles, blunt needles, ball-ends, and others are typical. Some tip configurations (ACE blades) contain a slightly different geometry that will enhance the affects of the generator's Advanced Cutting Effect (ACE) Mode. In this mode, the blade will make skin incisions without the blanching or thermal damage commonly seen with standard electrosurgery. The new E-Z Clean ACE Blade provides a wound site that will heal similar to a scalpel wound (comparable Histopathology) when used in conjunction with the ACE mode. When not being used to perform skin incisions the ACE Blade functions as a standard E-Z Clean blade in all cutting and coagulating modes. This submission also includes the option of a guard or nosecone on some configurations of electrodes. This nose cone provides additional dielectric protection at the junction where the E-Z Clean electrosurgical electrode is connected to an electrosurgical pencil.

The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.

The suction coagulator is a hand held electrosurgical device used for coagulation and aspiration during electrosurgical procedures. The device is available in two different configurations: hand controlled and foot controlled models. Both models are supplied with holsters.