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Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in saline irrigation fluid. Specific indications: - transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis) - lysis of intrauterine septa - endometrial ablation .

The Olympus Resection Electrodes that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting. The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft). The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, rollers, needles or buttons. All subject Resection Electrodes are single-use electrodes and are delivered sterile and are used in combination with a reusable HF cable (the HF cable is not subject to this submission).

The ConMed/Linvatec LightWave™ Integrated Electrode Ablators are intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids.

The ConMed/Linvatec LightWave" Integrated Electrode Ablators are a modification of the currently marketed 3.2 mm UltrAblator electrode (Linvatec, K030720) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device. One version incorporates handcontrolled buttons to actuate the "cut" and "coag" functions of the electrosurgical generator. Another version is actuated by foot-control to control "cut" and "coag" functions of the electrosurgical generator. The hand-controlled and foot controlled version consists of an electrical insulation coated electrode and ceramic insulator attached to an integrated handle and cord set, allowing attachment to commonly available electrosurgical generators in distribution. A third version of the ConMedILinvatec LightWave™ Integrated Electrode Ablators incorporates a suction/aspiration feature and is a modification of the currently marketed 3.2 mm Ult Ablator electrode (Linvatec, K993885) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device, and is similar in technology to Heatwave Hand-Controlled Electrode (Conmed, K021299) and the VAPR™ 3.5mm 90° Suction Electrode (Mitek, K002422), which incorporate aspiration or suction. The device is similar to the hand-controlled device and will also have suction capability and attach to commonly available suction equipment. This electrode will be hollow allowing for the removal of irrigating fluids during surgical procedures. The front switch contained in the hand-controlled devices provide the surgeon with electrosurgical cut (ablate) capability when depressed. The rear button activates electrosurgical coagulating (coag) current.

Reprocessed electrosurgical electrodes are intended for precision cutting, dissecting and cauterizing soft tissue. These devices are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.

SterilMed's reprocessed electrosurgical electrodes are a monopolar electrosurgical instruments consisting of a tungsten tip, stainless steel housing, and several layers of insulation.

The UltrAblator™ Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following: Knee 1. Meniscectomy 2. Lateral Release 3. Chondroplasty 4. Synovectomy 5. ACL Debridement 6. Plica Removal 7. Meniscal Cystectomy Ankle 1. Fracture Debridement 2. Excision of Scar Tissue 3. Synovectomy 4. Chondroplasty Wrist 1. Synovectomy 2. Cartilage Debridement 3. Fracture Debridement Shoulder 1. Labral Tear Resection 2. Synovectomy 3. Excision of Scar Tissue 4. Acromioplasty 5. Bursectomy 6. Subacromial Decompression 7. Chondroplasty Elbow 1. Synovectomy 2. Tendon Debridement 3. Chondroplasty

The UltrAblator™ Electrode is a monopolar electrode which will be packaged individually or in a kit containing an UltrAblator™ Electrode, ConMed electrosurgical pencil, and a ConMed electrosurgical dispersive pad. The electrode is connected to an electrosurgical generator via the ConMed electrosurgical pencil. The device is inserted into the joint. Upon activation of the generator, the tip of the device electrosurgically ablates and coagulates tissue. The UltrAblator™ Electrode is a modification of Linvatec's Ablator Electrode which received FDA clearance under 510(k)# K983652 on March 23, 1999. The electrode will be made available in a range of sizes from 2.4" to 6.3" inches in working length, and in three angles, 0°, 30°, & 90°. The insulating material will be changed from polyolefin shrink to Vitek powder coat.

The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.

The HeatWave™ Electrode is a sterile, single-use, monopolar electrode designed to be used in conjunction with an electrosurgical generator via an electrosurgical pencil and a dispersive pad. The HeatWave Electrode will be sold individually and/or in a kit containing an electrode, electrosurgical pencil and an electrosurgical dispersive pad.

Device is used for cutting and/or coagulation during open surgical procedures.

Not Found

The bipolar ball electrodes are designed for electrosurgical coagulation of soft tissue in a bloody, irrigated or wet surgical field.

Bipolar Ball Electrodes