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The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.

The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.

This instrument has been designed for use in a medical facility under the supervision of a trained physician. It has been designed for general(open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes(fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery(cutting and coagulation), light sources and other ancillary equipment.

The Electrosurgical Unit XUES-41 produces the high frequency current waveform delivered to tissue via the electrosurgical accessories and electrodes. When the high frequency current is fed through tissue, it generates heat rises, causing changes from protein degeneration to desiccation and vaporization.

OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic surgery.

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3). - (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series. - (2) Olympus SonoSurg Transducer SonoSurg-T2H. - (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51). This device is intended to cut and coagulate soft tissue for obstetric/ gynecologic surgery, and for open and laparoscopic surgery.

< BF-40 Series> These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree. <BF-240 Series> This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree. <BF-160 Series> These instrument have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

< BF-40 Series> These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree. <BF-240 Series> This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree. <BF-160 Series> These instrument have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

This instrument has been designed to be used with the ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

DISPOSABLE ASPIRATION NEEDLE NA-200H is a modified version of NA-10J-1 Aspiration Needle, which was cleared #K973128. When compared with the predicate device, the following modifications have been made to the NA-10J-1 needle: 1. The NA-200H is provided pre-assembled, sterile single use disposable. 2. The NA-200H includes a sterile single use disposable syringe for aspiration. The K12-MS2666 Syringe (VACLOK Syringe and Stopcock) is attached to the aspiration port on the handle section of the NA-200H. These devices will be provided sterile single use. We are offering these devices together to improve convenience to the customer. The syringe to be included in the package has been cleared by FDA as a cardiologist or radiologist during angiographic or radiologic, it is intended to be used for aspiration in this submission.

This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.

This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.

Olympus BIOPSY FORCEPS has been designed to be used with an Olympus endoscope to collect tissue samples within the upper and lower digestive tract and to extract the tissue samples though the biopsy forceps with suction.

This instrument has been designed to be used with an Olympus endoscope to collect tissue within the upper and lower digestive tract and to extract the tissue sample through the biopsy forceps with suction. The Olympus Biopsy Forceps XBO1-824-18/19/20 are composed with three major components as follows: 1. Biopsv Forceps (XBO1-824-18/19/20) The mechanism of subject device for collecting blopsied tissue is that biopsled tissue is caught onto Specimen trap by injected water through the biopsy forceps and it is possible to collect 5 samples continually. 2. Suction Tube (XBO1-824-18C) This device is for connecting the thumb ring valve to the suction source. 3. Specimen Trap (XBO1-824-18D) The Specimen Trap has a fitter for the specimen to be aspirated through the Aspiration Lumen, which can be attached onto the proximal section of the Biopsy Forceps. The Specimen Trap is comprised with five independent filters, which are arrayed serially. After it catches the specimen, the filter that holds the specimen, is extruded from the proximal handle of the Biopsy Forceps, and snapped off into an individual section. To avoid unexpected breakage of the Trap, the Trap Support guides the sections of the Traps. When the section of the Specimen Trap is inserted into the proximal handle, it will make a "click" sound, and the first Trap will be centered at the axis of the Aspiration automatically.

This instrument has been designed to be used with an Olympus endoscope for washing, and spraying contrast media or medicine (e.g. anesthetics) within the airway, including tracheobronchial tree.

Spray Catheter PW-6C-1 has been designed to be used with an Olympus endoscope to perform washing, and spraying of contrast media or medicine (e.g. anesthetics) within the airway, including the tracheobronchial tree. PW-6C-1 is used in combination with an way, mologing the spray fluid continuously. Both PW-6C-1 and MAI-929 are non-sterile, reusable.

The Olympus XENF-DP Rhino-Laryngofiberscope, its accessories and ancillary equipment have been designed to be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis within the upper airway which includes the nasal cavity, nasopharynx, hyporpharynx and larynx.

This subject device "XENF-DP Rhino-Laryngofiberscope" is used for observation within nasal and nasopharyngeal lumen. This endoscope enables use of 2 types of light sources, a detachable single use battery light source powered and a light cable light source.

This instrument has been designed to be used with an Olympus endoscope I mis instrument mas count in the biliary and pancreatic ducts, although it is not designed for the deep insertion into the pancreatic duct.

The subject device is a cannula which has a bending function (angle wire), to be used in accordance with Intended Use of the Device. This bending function enables the subject device to be manipulated in 2 directions and leads to easier insertion into the biliary and pancreatic ducts.