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Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 and EG-530UT2, are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.

Fuiinon/Fujifilm Ultrasonic Endoscopes EG-530UR2 and EG-530UT2 are modified versions of our previously-cleared EG-530UR and EG-530UT via K063847. The modified models are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment when used with a Fujinon/Fujifilm's ultrasonic processor, which remains the same as K063847. The modified models are used in combination with a Fujinon/Fujifilm's ultrasonic processor. video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EG-530UR2 and EG-530UT2 model emits ultrasound wave and scans the reflected signals to provide ultrasonic images.

This device is intended for the visualization of the lower digestive tract, specifically. for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

Fujinon Colonoscope EC-530HL2 and EC-530LS2 are modified versions of our previouslycleared Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5 as described in K041903. The modified models are intended for observation, diagnosis, and endoscopic treatment of the lower digestive tract, which includes rectum, sigmoid colon, and large intestine, which remains the same as K041903. The endoscopes are comprised of three general sections: an operation section, a flexible portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The flexible insertion portion contains glass fiber bundles, several channels and a charged couple device (CCD). The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity thereby providing enough light to the CCD to capture an image and display the image on the monitor. The endoscope also contains several channels to deliver air/water, provide suction and a working channel. The forceps channel or working channel is used to introduce endoscope accessories such as biopsy forceps. The umbilicus contains electronic components needed to operate the endoscope when plugged to the video processor and the light source. The modified models are used in combination with Fujinon's video processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices.

The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, light source, monitor, recorder and various peripheral devices. The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, video processor, monitor, recorder and various peripheral devices.

This system is intended to be used in conjunction with Fujinon endoscopes to provide illumination, visual display and data storage during endoscopic procedures. The EPX-4440HD Digital Video Processor consists of three components used in conjunction with one another: The VP-440HD Video Processor: The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor also incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor also provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 120V/60MzJO.8A. The Processor is housed in a steel-polycarbonate case measuring 390X105X460mm. The XL-4450 Light Source: The Fujinon endoscope employs fiber bundles to transmit light from the light source and subsequently to the body cavity. The Light Source employs a 300W Xenon lamp with a 75W emergency back-up Halogen lamp. Brightness control is performed by the user. The device is AC operated at a power setting of 120V/60MzJ3.3A. The Processor is housed in a steel-polycarbonate case measuring 390X155X485mm. The DK-440E Keyboard: The Keyboard is used to enter pertinent procedural information (patient, physician, date, etc) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-4440HD Processor. The Keyboard resembles a standard computer keyboard in size and shape.

The sterile overtubes are intended to be used as accessories with the Fujinon Enteroscopes and Colonoscopes cleared for use with overtubes. The overtubes are used to assist with the movement of the scopes inside the upper or lower digestive tract. The sterile overtubes are intended to be used as accessories with the Fujinon Double Balloon Enteroscopy system, which is used for the optical visualization of the gastrointestinal tract

The Fujinon double balloon enteroscopy system (K040048) and EC-450B15 (K090116) utilize specialized overtubes to ensure complete positioning of the enteroscope or colonoscope in the digestive tract and to ensure the tip of the scope can be smoothly inserted to reach the area of diagnosis. The overtube (TS-12140) was included in the original 510(k) K040048 and the overtube (TS-13101) was included in 510(k) K090116 with the EC-450BI5. This submission includes the following items: TS-12140 Over Tube Originally included in the K040048 as non-sterile. TS-13140 Over Tube TS-13101 Over Tube Including in K090016.

The device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.

The device is intended for the optical visualization of the gastrointestinal tract. This includes the recturn, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment. The Fujinon double balloon enteroscopy system utilizes specialized balloons and over-tube to ensure complete positioning of the colonoscope. The tip of the scope can be smoothly inserted to reach the area of diagnosis. This allows for access to hard to reach areas within the bottom portion of the small intestine. The EC-450B15 consists of the following portions / parts: - . Control portion - to provide grip for holding the endoscope and for the operation of the endoscope. - LG Flexible Portion Contains the light guide, air/water supply tube, suction tube, . and cables. - Bending Portion . - Distal End Contains objective lens, air/water nozzles, forceps channel. . The EC-450Bl5 is used with balloons (BS-1 or BS-2) and an Over-Tube (TS-13101), as well as the balloon pump. The balloon pump, balloons and over-tube were introduced and included as part of the Double Balloon Enteroscopy 510(k). The EC-450BI5 is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.

The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.

The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally. The EG-530N consists of the following portions / parts: - Control portion to provide grip for holding the endoscope and for the operation of the endoscope. - LG Flexible Portion - Contains the light guide, air/water supply tube, suction tube, and cables. - Bending Portion - Distal End - Contains objective lens, air/water nozzles, forceps channel. The EG-530N is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.

The EG-530UR and EG-530UT ultrasonic endoscopes are intended to be used with the SU-7000 ultrasound I ho system is used for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas), as well as observation and diagnosis of submucosal and peripheral organs using ultrasonic images, and endoscopic treatment.

The EG-530UR and EG-530UT are medical ultrasonic gastrointestinal endoscopes. They are intended for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas) using an Ultrasonic endoscope, observation and diagnosis of submucosal and perioheral organs using ultrasonic images, and endoscopic treatment at medical facilities under the management of physicians. These endoscopes are used in combination with a processor, light source, cart, ultrasonic processor (SU-7000), and video printer. The endoscopes are used with a single use balloon. The endoscopes have a groove on the tip to hold the balloon in place. The SU-7000 is an ultrasonic processor that is used with a medical ultrasonic endoscope (EG-530UR or EG-530UT). The processor connects to the ultrasonic endoscope, which emits ultrasound in a body cavity by driving an ultrasonic transducer of the endoscope. It also processes the reflection ultrasonic signal received by the transducer and coverts it to an ultrasonic image.

The device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

The Fujinon G5 Bronchoscopes are medical endoscopes used for the observation, diagnosis, and endoscopic treatment of the trachea and broncho. The G5 Bronchoscopes are offered in a 200 and 400 series. The EB-250S represents the G5 Bronchoscope 200 series and the EB-470S represents the G5 Bronchoscope 400 series. The G5 Bronchoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons. The J-Port was repositioned. The J-Port is used as a jet water wash port. The J-Port was repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging. A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage. The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable. The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same. The G5 Bronchoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning. The G5 Bronchoscopes are used with the same processors, monitors, hard carts as the predicate devices. Each Duodenoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual. The Fujinon G5 Bronchoscopes are used in conjunction with other peripherals specified in the Operation Manual such as: Light Source, Processor, Cart, Data Keyboard, Foot Switch, Monitor, Video Printer, Camera and Hard Copy Unit, VCR, ElectroSurgical Instruments.

The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb.

The Fujinon GS Gastroscopes are medical endoscopes used for visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The G5 Gastroscopes are offered in a 200 and 400 series. The EG-250WR5 represents the G5 Gastrooscope 200 series and the EG-450WR5 represents the G5 Gastroscope 400 series. The G5 Gastroscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons. A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage. The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection. The valves are now external and removable. The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same. The G5 Gastroscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning. The G5 Gastroscopes are used with the same processors, monitors, hard copy units, and carts as the predicate devices. Each Gastroscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual. The Fujinon G5 Gastroscopes are used in conjunction with other perified in the Operation Manual such as: Light Source / Processor / Cart / Data Keyboard / Foot Switch / Monitor / Video Printer / Camera and Hard Copy Unit / VCR / Electrosurgical Instruments.

The device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

The Fujinon G5 Duodenoscopes are medical endoscopes used for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. The G5 Duodenoscopes are offered in a 200 and 400 series. The ED-250XT5 represents the G5 Duodenoscope 200 series and the ED-450XT5 represents the G5 Duodenoscope 400 series. The G5 Duodenoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons. A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage. The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection. The valves are now external and removable. The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same. The G5 Duodenoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning. The G5 Duodenoscopes are used with the same processors, monitors, hard copy units, and carts as the predicate devices. Each Duodenoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual. The Fujinon G5 Duodenoscopes are used in conjunction with other peripherals specified in the Operation Manual such as: - Light Source - Processor - Cart - Data Keyboard - Foot Switch - Monitor - Video Printer - Camera and Hard Copy Unit - VCR - ElectroSurgical Instruments