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The OES Elite Telescopes are indicated to provide the user with the means for visualizing diagnostic and therapeutic surgical procedures. The device is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

The OES ELITE Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The OES ELITE Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The OES ELITE Telescopes will be marketed as individual telescopes. The OES ELITE Telescopes are available in 4 mm diameters with four different directions of view (0°, 12°, 30°, 70°) each to allow use for various applications in accordance with the intended use as submitted with this 510(k). The OES ELITE Telescopes will be delivered with a protective tube WA2P400A which is subject to this 510(k) submission.

Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices are intended to be used by qualified physicians to provide access and visualization of internal structures such as bladder, urethra, kidneys, prostate and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing).

Endoservice Endoscopic Instruments & Accessories are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility. The urological-gastroenterological accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue, body cavities, hollow organs and canals (grasping, cutting, dissecting, coagulating and suturing). The Endoservice Endoscopic Instruments & Accessories and Minimally Invasive gastrointestinal GI and genitourinary GU Devices contain different components such as Scissors, Forceps, Connections (inner Rod, Sheath insulated), Handles, Sheaths, Endoscopes, Cystoscopes, Resectoscopes, Urethrotomy, Retractor, Forceps, Scissors, Punches, Tubes, Trocars, Trocar Sleeves, Sheat, Needle holder, and Inserts. The device is made out of following materials: Body: steel 1.4301; plastic PPSU Handle: adhesive hysol-resin Lens: saphir

ACMI® M4™ Series Telescopes are intended for use in patients requiring endoscopic evaluation or for surgical procedures of the urological or gynecological systems.

ACMI M4 Series Telescopes are optical devices that are used with endoscopic accessories in diagnostic and surgical procedures of the urological and gynecological systems. ACMI M4 Telescopes are optical devices that are used along with endoscopic accessories for diagnostic and therapeutic procedures in urology and gynecology. They are designed to be inserted through an endoscopic device such as an ACMI cystourethroscope, hysteroscope, or resectoscope. M4 Telescopes are (4mm diameter, 31 cm long) rigid autoclavable optical instruments available in four directions of view: M4-0A, direct (0°), M4-12A, operative (12°), M4-30A, foroblique (30°), and M4-70A, lateral (70°), to assist the physician in visualization of the anatomy during diagnostic and surgical procedures.

The endoscopes serve to visualize the inside of the patient via natural or surgically generated access. For examination, diagnosis and/or therapy by personnel trained in the use of endoscopic instrumentation used in various medical disciplines, such as surgery, urology, gynecology, and ENT.

An endoscope with 1.9 mm and 2.7 mm diameter, typically used in endoscopy in infants and babies.