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Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed for endoscopic clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects <3cm, bleeding ulcers and arteries <2mm, polyps<1.5cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. This device is not intended for the repair of GI tract lumenal perforations.

The HX-5/6-1 Endoscopic Clipping Device is available as a set consisting of the HX-5/6-1 Endoscopic Clipping Device main body and clips. These clips are attached to the hook when the wire is advanced out of the distal end of the device. Applying tension to the control wire will "seat" a step on the clip onto the distal end of the stainless steel coil. The FEP tube sheath may then be advanced to cover the distal end of the coil and the attached clip. The device may then be inserted through the instrument channel of the appropriate endoscope. When the device has been advanced to the area of interest, the tube sheath is retracted by moving the tube joint distally until an audible "click" is heard. When the control section slider is pulled proximally, the control wire is tensioned, and the clip is pulled into the clip body (pipe). Due to the shape of the clip itself, when the clip is pulled into the clip pipe, it will initially open wider. As it is pulled in even further, the clip pipe will force the clip arms to close on the target tissue and deploy.

The Olympus UM-2R and UM-3R Ultrasonic Probes have been cleared for use within the gastrointestinal tract in 510(k) #K944610. The Olympus UM-2R and UM-3R Ultrasonic Probes have been designed for use in combination with Olympus Endoscopic Ultrasound System for intraluminal sonographic imaging of the urinary tract. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraluminal ultrasound for urinary tract. Previously cleared indications=Intraluminal ultrasound for gastrointestinal tract.

In routine examination of the urinary tract, there are situations where the physician prefers to perform an intensive examination, observation, and diagnosis of the urinary tract. The ponventional type therapeutic urethro-cystoscope limits the physician's ability to access certain areas of interest. The UM-2R / UM-3R Ultrasonic Probes, when used with an endoscope offer transendoscopic access to the urinary tract. The 2.4 mm insertion tube of these probes can be advanced through strictures and anatomical ducts. The Olympus Ultrasonic Probes to be used in conjunction with therapeutic urethro-cystoscope with a minimum capacity size of 9Fr.. A probe-driving unit controls the rotation of the transducer. The UM-2R and UM-3R probes produce a B-mode scans using the de-aerated water immersion method and offer 360 degree mechanical/radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4 mm and the length is 2050 mm. Both probes incorporate similar design, construction, intended use, and method of operation. The only difference between these two probes is that the UM-2R probe operates at 12 MHz and is compatible with both Olympus EU-M30, EU-M20 and EU-M3 Endoscopic Ultrasound Systems, while the UM-3R probe operates at 20 MHz and is compatible with the EU-M30 and the EU-M20 Endoscopic Ultrasound System.

The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures. The telescopes and recommended ancillary equipment will be sold nonsterile and can be reused after proper cleaning and sterilization before usage as outlined in the instruction manual. The endoscopes are made of stainless steel and are comprised of a combined optical (rod-lens system) and illumination system.

The intended use of the Olympus USU is identical to the currently marketed CUSA® system 200 which was cleared for marketing in 510(k)#s K#910696 and K#921251. Both systems are used for smashing and aspirating disease tissues in the Neuro surgery field. The Olympus Ultrasonic System is indicated for use in the fragmentation, emulsification, and aspiration of soft tissue in the neurosurgery field.

The Olympus USU is specially designed for open procedure in the Neurosurgery field, in order to smash and aspirate disease tissue such as cerebral tumor, cerebral hematoma, cerebral aneurysm/varicosity. Actuation mechanisms of the above systems is the same as the USU based as the following: The small ultrasound vibration which is generated by the ultrasound actuator built-in hand piece, is transferred to the probe which is mounted on the edge of hand piece. The tissue is smashed by the shock force exchanged from the vibration on the probe with pushing to the tissue. The smashed tissue is taken out by the suction space between the probe and sheath of hand piece. The Olympus USU mainly is used in microscopic surgery.