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The CoralWell™ Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

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The SeleneView® (model: HC29, HC29-G, HC35, HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures. SeleneView® is intended for use in professional healthcare facility environments such as hospitals and clinics. SeleneView® is designed for use in adults.

SeleneView® Single-Use Digital Hysteroscope consists of a handle, insertion and endoscope cable. SeleneView® is provided sterile (sterilized by ethylene oxide [EO]) and intended to be single-use. The built-in light emitting diode (LED) at the distal tip of SeleneView® Single-Use Digital Hysteroscope provides a light source, the lens module captures the light signal, then the complementary metal-oxide-semiconductor (CMOS) image module converts the light signal into an electrical signal; the endoscope cable connects SeleneView® Video Processor, which provides power and processes video signal from the endoscope. The SeleneView® is intended to be used combined with ViewHub® Video Processor to perform its intended function and the ViewHub® has been 510(k) cleared in K233779. SeleneView® Single-Use Digital Hysteroscope has the following physical and performance characteristics: - Camera and LED light source at the distal tip - Sterilized by Ethylene Oxide - For single-use

The BubbleView™ Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The BubbleView™ is intended to provide visualization via ViewHub® video processor and can be used with endoscopic accessories. BubbleView™ is intended for use in a hospital environment or medical office environment. BubbleView™ is designed for use in adults. ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes.

The Single-Use Digital Flexible Cystoscope System consists of BubbleView™ Single-Use Digital Flexible Cystoscope (consists of a handle with control lever, endoscope cable and access port for accessories, and a flexible body portion) and ViewHub® Video Processor with itsaccessories including power cables. The BubbleView™ is provided sterile (sterilized by EQ) and intended to be single-use. The ViewHub® is a reusable multi-patient use device. The built-in LED at the Distal tip of the BubbleView™ Single-Use Digital Flexible Cystoscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal into an electrical signal: the endoscope cable connects the BubbleView™ to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handleconnected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion: the instrument channel delivers water and other instruments. The ViewHub® Video Processor is a video imaging system that receives video signals from the connected endoscope, controls the lightat the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.

The LoopView® is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree. The endoscope is intended to provide visualization via MACROLUX™ video processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults. The ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes.

The Single-Use Diaital Flexible Bronchoscope System consists of LoopView® Single Bronchoscope (consists of a handle with control lever, endoscope cable and access port for accessories, and a flexible body portion) and ViewHub® Video Processor with its accessories including power cables. The LoopView® is provided sterile (sterilized by EO) and intended to be single-use. The ViewHub® is a reusable multi-patient use device. The built-in LED at the Distal tip of the LoopView® Single Bronchoscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal; the endoscope cable connects the LoopView® to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handle connected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion; the instrument channel delivers water and other instruments. Suctioning of saliva and mucus from airway is possible through the suction system. The ViewHub® Video Processor is a video imaging system that receives video signals from the connected endoscope, controls the light at the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor. The LoopView® Single-Use Digital Flexible Bronchoscope has the following physical and performance characteristics: - Maneuverable tip controlled by the user - Flexible insertion cord - Camera and LED light source at the distal tip - Sterilized by Ethylene Oxide - For single-use The ViewHub® Video Processor has the following physical and performance characteristics: - Snapshot, white balance, zoom and HD video output - supports HDMI video output formats - Touch Panel - Reusable

The device 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.

The Single-Use Digital Flexible Ureteroscope System consists of CoralView® Single-Use Digital Flexible Ureteroscope (consists of a handle with control lever, endoscope cable and accessories, and a flexible body portion) and ViewHub® Video Processor with its accessories power cable and connector cables. The Coralliew® is provided sterile (sterilized by EO) and intended to be single-use. The ViewHub® is a reusable multi-patient use device. The built-in LED at the Distal tip of the CoralView® Single Ureteroscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal; the endoscope cable connects the CoralView® to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handle connected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion; the instrument channel delivers water and other instruments. The ViewHub® Video Processor is a video imaging system that receives video signals from the light at the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.