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The Henke-Sass, Wolf Resection Instruments are intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, incision, coagulation, cauterization of minor bleedings, resection of tissue, vaporization and enucleation, and as the surgeon deems appropriate. The instruments are intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: - . Dilation of the urethra, and cold-slitting of urethral strictures - . Trans-urethral incision and resection of the prostate - . Trans-urethral removal of bladder tumor - . Trans-cervical resection and ablation of the endometrium - . Trans-cervical resection of fibroids

The Henke-Sass, Wolf Resection Instruments consist of various components that assemble into and/or work as a diagnostic and therapeutic resectoscopic system in urology and gynecology. This submission is comprised of rigid working elements (resectoscopes), sheaths, obturators, electrodes (bipolar and monopolar), and HF cables. With the exception of the electrodes, the subject devices are provided non-sterile and reusable. The electrodes are provided sterile and are single-use. Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.

a. Endoscopes: The Henke-Sass, Wolf Cystoscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of the anatomy, as the surgeon deems appropriate. The Henke-Sass, Wolf Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site. b. Urology Instruments: The Henke-Sass, Wolf Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

The Henke-Sass, Wolf Cystoscopes, Hysteroscopes and Accessories are composed of cystoscopes, hysteroscopes and cystoscopic accessories, which provide the user with the means for endoscopic diagnostic and therapeutic procedures. Examples of use of the product include the visualization and manipulation of anatomy, biopsy, and as the surgeon deems appropriate.