Search Results

The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.

The Gyrus General Purpose Electrosurgical Generator operates only in bipolar mode. It has controls for output waveform type and power. The unit has readouts for set power and waveform. There are two custom 9-way connectors on the front panel for PlasmaCision instruments and PlasmaKinetic bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the generator are the disposable instruments, footswitch and a power cable.

The Plasmacision and Plasmablend Electrodes are indicated for Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures.

The Gyrus PlasmaCision and PlasmaBlend electrodes are bipolar electrosurgical instruments with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic surgery under carbon dioxide gas or air insufflation. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The PlasmaCision and PlasmaBlend electrodes may also be used in general surgical procedures. The instruments are to be used only with the Gyrus General Surgery RF Workstation. Activation of the instruments is achieved via footswitch control. The Instruments are available with and without aspiration (suction) / irrigation lines. On such equipped instruments, this provides additional functionality to the device by increasing its range of capabilities within the procedure. The suction / irrigation capable versions incorporate a lumen / Y connector and male connector with polymeric tubing for adaptation to suction / irrigation systems. The instruments are, like other Gyrus bipolar electrosurgical instruments, available in a number of different shaft lengths and diameters, chosen by the surgeon to be most appropriate for the procedure to be undertaken. The instruments have a multipole arrangement at the patient interface. The instruments consist of three individually isolated conductors that act as the tissue effectors. A PlasmaBlend output is a blended cut and coagulation output that is delivered to the L09 instrument. The ratio of cut to coagulation of this output is selectable by the user and this allows the user to select the amount of haemostasis created during cutting. This output is controlled by the Gyrus General Surgery RF Workstation.

The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions: - Rhytides of the face - Superficial skin lesions - Actinic Keratosis - Viral papillomata - Seborrhoeic Keratosis The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions: - Rhytides of the face . - Superficial skin lesions . - . Actinic Keratosis - . Viral papillomata - Seborrhoeic Keratosis . Accessories included with the generator are a cable assembly/instrument, power cable and a footswitch.

The Gyrus PlasmaCision Laparoscopic Spatula is indicated for resection and Coagulation of son and blood vessels in laparoscopic and general surgical when used with the Gyrus PlasmaKinetic Generator or the Gyrus PlasmaKinetic SuperPulse Generator.

The Gyrus PlasmaCision Laparoscopic Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic with the saper carbon dioxide gas or air insufflation. The instrument will pass through a 5mm cannula or through an operating laparoscope's working channel of 5mm minimum diameter. The instrument is to be used only with the Gyrus PlasmaKinetic Generator, the Gyrus SuperPulse Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment. The device has the functionality to dissect, resect or vaporise tissue with haemostasis, to coagulate tissue and blood vessels and to blunt (cold) dissect tissue.

Electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.

The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow the physician to easily manipulate the device for electrosurgical coagulation including the sealing of vessels. The overall length of the device is nine (9) inches. The device will be available in three distinct jaw configurations. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad.

The Gyrus PlasmaKinetic Superpulse System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

The Gyrus PlasmaKinetic Superpulse System Generator Description: is an Electrosuraical device with a bipolar mode of operation: The generator has controls for output waveform type and power. The unit has readouts for set power and waveform. The two physically identical connectors on the front panel support PlasmaKinetic, PlasmaKinetic Superpulse (RHS only) and 4mm bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the generator are the electrodes, connector cable, footswitch and a power cable.

Electrosurgical cutting and mechanical dissection of tissue, during the performance of laparoscopic and general surgical procedures.

The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993. The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The cutting electrode is electrically isolated from the return electrode, enabling one electrode to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical cutting, and mechanical dissection are identical to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.

Mechanical cutting and electrosurgical coagulation of tissue during the performance of laparoscopic and general surgical procedures.

The device is a Class II medical device. The Everest LP Bipolar Scissors and Gyrus LP Scissors are a modification to the predicate device cleared under K904993. The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation and mechanical cutting during surgical procedures is similar to the predicate device cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.

Electrosurgical coagulation, electrosurgical cutting, dissection of tissue, irrigation and aspiration during the performance of laparoscopic and general surgical procedures.

The device is a Class II medical device. The Bipolar L Hook is a modification to the predicate device cleared under K904993. The Bipolar L Hook is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw to act as a refurn electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation, grasping and dissection of the tissue during surgical procedures is similar to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.

Electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

The device is a Class II medical device. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is a modification to the predicate device cleared under K904993. The Everest Bipolar MACRO, MICRO & MOLLY Forceps and Gyrus Bipolar MACRO, MICRO & MOLLY Forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K90493. The intended use, Electrosurgical Coagulation, Grasping and Dissection, during surgical procedures is similar to the predicate devices cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.