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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.

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.

The KARL STORZ Slim Nasopharyngoscope System is indicated to provide visualization and access of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic and therapeutic procedures in adult and pediatric patients.

The KARL STORZ Slim Nasopharyngolaryngoscope (Model Number: 11161V) is a reusable, flexible videoscope used for examination of the nasal lumens and airway anatomy. The KARL STORZ Slim Nasopharyngolaryngoscope System is identical to the KARL STORZ Flexible Video-Neuro-Endoscope System, which is currently distributed under K161112.

The AUTOCON III 400 is intended for use by qualified surgeons to provide a high frequency electrical current for monopolar and bipolar cutting and coagulation of tissue structures during surgical operations.

The AUTOCON III 400 is an electrosurgical unit (ESU) that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. AUTOCON III 400 offers a total of 37 different modes that can be divided into 4 main categories: Monopolar cutting (13 modes), monopolar coagulation (11 modes), bipolar cutting (4 modes), and bipolar coagulation (9 modes). The various modes in each category represent different settings that provide controlled cutting and coagulation. Each mode can be defined by the waveform type, power, crest factor, and duty cycle which correspond to different tissue effects. AUTOCON III 400 consists of a generator, a foot switch, and a power cord. A touchscreen user interface displays the connection status of accessories and peripherals and allows the user to select modes, power settings, effect, and various other settings. AUTOCON III 400 has a bipolar socket, a monopolar socket, and neutral electrode socket for the instruments and accessories with which the generator is compatible. Contact quality indicators are displayed to indicate if the neutral electrodes are correctly connected or not.

The KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures such as shunt placement, tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration in pediatrics and adult population.

The components subject of this submission are: (1) the KARL STORZ ShuntScope (Model Number: 28164SSA), (2) the examination sheath (Model Number: 11577KA) and (3) operating sheath (Model Number: 11577KE)