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The Flexible Suction Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. It is also used as a steerable ureteral catheter that establishes a conduit for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy.

The Flexible Suction Ureterorenoscope (Model: US27G-12-EU; US27G-12-US; US33G-17-EU; US33G-17-US; US38G-20-EU; US38G-20-US) is intended to be used with the Video Processor (cleared via K211169). The Flexible Suction Ureterorenoscope is also used as a steerable ureteral catheter. The Flexible Suction Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Suction Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a push button for suction, a connector for suction tubing, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the Video Processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section is steered by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, optical fibers for transmitting illumination from the LED inside the Handle, and the distal opening of the working channel. The Endoscope Connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope. Same as the predicate, the subject device is also provided in 2 deflection versions (US/EU deflection).

Mechanism of action:

The light emitted from the distal tip of the Flexible Suction Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LED on the endoscope. The suction button enables aspiration through the working channel.

Flexible Suction Ureterorenoscope has the following physical and performance characteristics:

• Steerable tip controlled by the user
• Flexible insertion cord
• Camera at the distal tip
• LED in the handle and transmitted to the distal tip by optical fibers
• Suction button and connector
• Sterilized by Ethylene Oxide
• For single use

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