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For telescopes with diameter ranging from 3mm-5mm The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics. For telescopes with diameter ranging from 5.5mm- 11mm The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults.

The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 6°, 30° and 45° direction of view, diameters ranging from 3mm to 11mm and working lengths from 18cm- 50cm.

The Flexible Video Cysto-Urethroscope C-VIEW is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

The Flexible Video Cysto-Urethroscope C-VIEW (Part Number: 11272VUE) is intended to be used with multiple compatible CCUs: C-MAC (8403ZX, cleared via K182186) and C-HUB II (20290301, cleared via K182186). Identical to the predicates, the scope cannot be operated on its own because it is a videoscope whose image data output is provided in the form of video signals and sent to the CCU for decoding and display. Therefore, when the scope is connected to the compatible CCUs, it becomes the Flexible Video Cysto-Urethroscope C-VIEW System, which provides visualization and operative access in the urinary tract.

The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpieces. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.

The UNIDRIVE S III ENT is a motorized surgical device system used for the excision, ablation, removal or transection of bones/tissues during head, neck, ENT, or otoneurological surgical procedures. The system components include a control unit used in conjunction with the High-Speed Micro Motor that houses the high-speed handpieces and DrillCut-X® II Shaver handpieces. The modifications made to the UNIDRIVE® S III ENT system is the addition of the DrillCut-X® II-35 and DrillCut-X® II-35 N Shaver handpieces. Additional accessories used with the UNIDRIVE S III ENT system include the shaver blades, sinus burrs and the sinus burr 35k.

The Image 1 S is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization, image recording and documentation during general endoscopic and microscopic procedures. The Image 1 S 4U camera head is intended to the Image1 S Camera Control Unit (CCU) and compatible endoscope for visualization, image recording and documentation during general endoscopic and microscopic procedure.

The Image1 S camera control unit is a medical device which consists of the Image1 S Connect (TC200US), Image1 S Connect II (TC201US) modules and the link modules. The link modules are Image1 S H3-Link (TC300US), Image1 S X-Link (TC301US), Image1 S D3-Link (TC302US) and Image1 S 4U-Link (TC304US). The Image1 S Connect (TC200US) and the Image1 S Connect II (TC201US) modules can be connected to a minimum of one and a maximum of three links modules. The modularity enables customers to customize their Image1 S system to their specific current and future video needs. The Image1 S includes, but not limited to, the following features: • Brightness control • Enhancement Control • Automatic Light Source Control • Shutter Control • Image/Video Capture When the Image1 S Connect II module is used with the 4U-Link and the Image1 S 4U camera head, it can output a 4K image to the monitor and also offers 7 increments of zoom ranging from 1x to 2.5x. The software version of the Image1 S camera control is upgraded to version 4.0. Software version 4.0 introduces the KS HIVE, an Ethernet based interface that allows for communication between the Image 1 S camera control unit and certain KARL STORZ devices.

The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

The components subject of this submission are: the Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part Number: 11014L(U)), the Suction Valve (Part Number: 11301CE1/20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).

The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

The components subject of this submission are: the Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part Number: 11014L(U)), the Suction Valve (Part Number: 091011-20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US). The Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)) is a reusable, flexible video scope with an insertion shaft OD of 5.5 mm and length of 37 cm, a working channel OD of 2.3 mm, and a suction channel. Users can choose to attach either a LUER port with stopcocks (Part Number: 11014L) or a double LUER port (Part Number: 11014LU) to the working channel port. In terms of optics, it has direction of view of 0 degrees and field of view of 100 degrees.

The CMOS Video-Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.

The CMOS Video-Rhino-Laryngoscope System includes two main components: (1) the CMOS Video-Rhino-Laryngoscope (11102CM) and (2) the CCU. The CMOS Video-Rhino-Laryngoscope is compatible with two KARL STORZ CCUs: C-HUB and C-MAC.

The Flex-THOR System is indicated for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.

The Flex-THOR System includes two main components: (1) the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR), and (2) the Camera Control Unit (CCU). The insertion shaft of the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR) has an outer diameter of 2.9 mm and a working length of 675 mm with 8.5 Fr elliptical shaped distal tip (major diameter of 3.2 mm and minor diameter of 2.4 mm). Users can access the 1.2 mm working channel through the Luer ports.

The TELE PACK X LED is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic procedures.

The Telepack X LED is a portable and compact all-in-one imaging system that includes a 15 inch screen display, a camera control unit and internal LED light source, that is intended to be connected to a compatible device (camera head or videonendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy. The Telepack X LED includes a LED illumination light source to illuminate the intended area and a 15 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack X LED is a non-patient contacting and require only wipe down as needed.

KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.

The KARL STORZ New Generation Trocars provide a port of entry during endoscopic and laparoscopic procedures in pediatric and adult patients. The New Generation Trocars are available in diameters 2.5mm to 13.5mm and consist of a cannula, trocar, and a valve seal. The trocars combine single-use and reusable components since the valve seal is single use while the cannula and trocar are reusable components. The trocars are color coded by size and are available with pyramidal, conical, or conical-blunt tips. Reducers can be used to reduce the size of the trocar to accommodate a smaller instrument without losing pneumoperitoneum.