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The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.

This Special 510(k) discloses the modifications to the steps to carry out surface disinfection of the model 4500 handle that was reviewed and cleared in K232837. The Uro-G HD Flexible Cystoscope is a handheld, battery- operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. When fully assembled, the Uro-G HD Flexible Cystoscope- cannula and handle-has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.

The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra. Generally recognized indications for cystoscopy include: • Symptomatic voiding dysfunction • Hematuria • Bladder tumor surveillance • Recurrent lower urinary tract infections • Pelvic pain syndromes

The Uro-G HD Flexible Cystoscope System is a handheld, battery-operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. The fully assembled Uro-G HD Cystoscope System—cannula and handle—has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.

The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

The Uro-G cystoscope is a handheld, battery-operated portable cystoscope consisting of a sterile, disposable steerable endoscopic cannula and a reusable handle with a video monitor. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.

The Uro-N Cystoscope is intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.

The UroViu Uro-N Cystoscope System consists of (1) a hand-held, battery operated portable endoscope contained within a reusable handle and (2) a disposable cannula with an injection needle. The fully assembled Uro-N system has overall length of 522 mm (~21 inches). The disposable cannula working length is 269 mm (~11 inches) and total length is 388 mm (~15 inches). The injection needle is 23 Ga (OD 0.635mm, ID 0.318mm). The combined handle and cannula weigh less than 1 pound. The reusable handle has a connector and locking mechanism for attaching and detaching the cannula. The catheter is sterilized by electron beam and is intended for single use only.

The Uro-V cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

The UroViu Uro-V cystoscope is a handheld, battery-operated portable cystoscope. It includes a sterile, single-use disposable cannula and a reusable handle. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop a video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.