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The resectoscope system devices are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and gynecological electrosurgical procedures.

The Resectoscope System from RZ Medizintechnik GmbH consists of a working element, a shaft and an electrode. The Resectoscope System is used during endoscopic surgery in the fields of urology and gynecology with an optical system for visualization. The electrode is inserted into the shaft for use and the shaft is connected to the working element. The working element and shaft are supplied non-sterile, are intended for multiple use and must be sterilized before each use according to the instructions for use. The electrodes are supplied sterile and are intended for single use only. To use the Resectoscope System, the electrosurgical unit, pump and light source must be connected to the working element via appropriate connections such as cables, tubing and light guide cables. These components are not part of this 510(K).

The use of RZ Medizintechnik spinal endoscopes is indication of the intraoperative site during spinal endoscopic procedures and minimally invasive surgery.

The Cervical Endoscopes of RZ Medizintechnik are optical and fiberoptic-based rigid endoscopes provided with working channels of 2.2mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the cervical spine. The Discoscopes of RZ Medizintechnik are optical and fiberoptic based rigid endoscopes provided with working channels of 2.8 mm. 3.75 mm and 4.3 mm allowing the insertion of microsurgical instrumentation to perform endoscopic intervention within the spinal column such as endoscopic assisted discectomy. The Spinal endoscopes of RZ Medizintechnik may be attached to standard fiberoptic lightsources, commonly available video adapters and cameras such as Storz, Olympus and Wolf. The devices are reusable, delivered in non-sterile conditions and available in various designs: - Outer Diameters from 3,6 mm to 7,0 mm . - Diameter of working channel from 2,2 mm to 4,3 mm . - Working length from 95 mm to 208 mm . - Direction of view: 0°/6° (cervical endoscope) , 30° (discoscopes) . - Viewing angle 80° +- 5°

RZ Endoscopic (Minimally Invasive) Instruments and Accessories are indicated for various endoscopic procedures and include both electrical and non-electrical accessories.

RZ Endoscopic (Minimally Invasive) Instruments and Accessories consist of 1. Modular Forceps (reusable) 2. Single-Piece Forceps 3. Modular Forceps with Disposable Tips 4. Electrodes 5. Resectoscopic Instruments & Electrodes (reusable & disposable) 6. Electrosurgical Cables