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This product is intended to be used in combination with compatible colonoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

This product needs to be cut and connected to the endoscope tip of 9mm to 14mm, and medical tape needs to be prepared in advance to fix it into a cylindrical shape.

This product is intended to be attached to an endoscope.

The Disposable Distal End Tape Hood is installed at the tip of the endoscope to assist the endoscope in a clearer observation. It can push away the mucosa and keep a certain distance between the lens and the mucosa, thus maintaining the field of view.

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It is intended for use under endoscopic visualization for the morcellation and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures in urology.

The device includes a control unit, handpiece, footswitch, blades, waste bottle, collection bottle, and suction tube. The device is a reusable morcellation device which is intended for use under endoscopic visualization for the morcellation and removal of dissected benign prostatic hyperplasia (BPH) tissue during endoscopic surgical procedures.

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The Vena MicroAngioscope™ System is indicated for the visualization and diagnosis of vascular disease within the peripheral and coronary vessels.

The Vena MicroAngioscope System consists of two main components: the Vena MicroAngioscope™ (MA) and the Vena Camera Control Unit (CCU).

The Vena MA is a full-color, forward-viewing, imaging angioscope intended to be used in conjunction with fluoroscopy to aid in vascular interventions. Designed to be used either with a parent catheter or balloon irrigation, it has a working length of 160 cm with a diameter of 3 French (0.040") at the distal tip and 2.7 French (0.036") at the proximal end. A radiopaque marker band is positioned at the distal tip of the device. The device features a lighting system surrounding a high-resolution video endoscope which provides real-time, high-resolution imaging inside blood vessels. This allows for direct, accurate visualization of vascular structures and pathologies, enabling precise interventions. The proximal end consists of a bifurcated joint for connection to an LED illumination source and a camera connector of the Vena CCU. This angioscope must be connected to the Vena CCU to acquire images and emit light. The Vena MicroAngioscope is the sterile, single use applied part of the Vena MicroAngioscope System.

The Vena CCU is a compact, reusable imaging processor designed to interface with the MA to provide power, process images, and output live video. Housed in a durable metal enclosure, the CCU features a front panel interface with a dedicated camera connector for enabling visualization and an LED connector for powering the integrated illumination system. The unit includes two control buttons: one for capturing still images and another for recording video. The CCU requires the Vena MicroAngioscope to be attached to the front connectors for operation. Real-time imaging is transmitted via an HDMI output, allowing seamless integration with external monitors, while a USB port enables image and video storage. To maintain sterility in the angiosuite, the CCU is designed to be fully draped during procedures. Additionally, the CCU can be grounded by connecting to the equipotential grounding pin. By providing high-quality image processing and intuitive controls, the Vena CCU enables enhanced visualization and procedural efficiency in vascular interventions.

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The CO2 Pneumo-Dissector is used to dissect planes of soft tissue using pressure regulated, trigger-controlled pulses of medical grade CO2 gas. The device may be used in endoscopic, laparoscopic, and open procedures in which gentle blunt dissection of soft tissue planes is desired. Use the product only in accordance with the instructions provided.

The Pneumo Dissector Hook is a standard monopolar hook (based on design cleared under K140101) that can deliver CO2 flow on demand during general endoscopy and laparoscopic surgery. It is composed of two parts, a handle and an insert, which are linked using a nut-screw system. Also, the distal part of the instrument has the hook shape which is the monopolar electrode and the gas nozzle. It is a surgically invasive device intended for delivering pressurized CO2 gas to achieve separation of tissue layers prior to their dissection. The hook insert and tube are offered in lengths of 330mm and 200mm and diameters of 3.5mm and 5.0mm.
The handle has a connector for the CO2 as well as the banana plug or connector for electrosurgery. There is a push button to activate the CO2.
The nut-screw system is used to link the handle to the insert.
The insert consists of an insulated tube with a hook on the distal end.
The hook insert and tube are available in lengths of 330mm and 200mm and diameters of 3.5mm and 5.0mm.

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This Single-use Video Cholangioscope is intended to use in conjunction with endoscopic image processor to provide images for diagnostic and therapeutic applications in the pancreatico-biliary system and to provide a working channel for other endoscopic accessories.

This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.

The subject device, Cholangioscope Visualization System, comprises two components: the Single-use Video Cholangioscope and the Full HD Visualization Endoscopic Image Processor.

The Single-use Video Cholangioscope is a single use sterile device. It is composed of working channel, control wheel, operation section, insertion section (integrated with a video image sensor and lighting components), plug section, connection cable, water supply channel, suction channel and accessory- irrigation valve.

The operation section allows users to connect and operate the product. It includes two control wheels (large/small control wheel) to control the bending section at the insertion section to bend in four directions, a lock mechanism can be rotated clockwise to lock the control wheel in its current position, a working channel port can be used for inserting accessories and suction, a bundle mechanism is used to fix the Single-use Video Cholangioscope to the duodenoscope, a water supply port for connecting to the water supply tube, a suction port for connecting to suction tube with a flow control value, and a plug section for connecting with the image processor.

The insertion section can be inserted in patient entirely, and it includes a bending section and a distal end. The bending section can be bent >=50 degrees in four directions by the control wheel. The distal end includes a miniature Complementary Metal Oxide Semiconductor (CMOS) camera, two light-emitting diode (LED) illumination module, two water supply channels for inserting accessories and one working channel for discharging liquid to the suction tube.

The accessory-irrigation value can be connected to the working channel port to expand the working channel, and provide an injection-suction dual-purpose port that can be used for liquid supply or suction through the working channel.

This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images within the field of view from the body cavity on its LCD display and/or external monitor. The Full HD Visualization Endoscopic Image Processor has four models, they have the same hardware and the difference is mainly in the image adjustment functions.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, and general thoracoscopic surgical procedures. The system is also indicated for selected thoracoscopically-assisted cardiac surgical procedures using the non-force feedback instruments. The system is indicated for adult use.

The da Vinci Surgical System (IS5000) is a software-controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Side Console (Console), a Patient Side Cart (Robot), and a Vision System Cart (Tower) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

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da Vinci SP Surgical System, Model SP1098
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach, and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

da Vinci SP Instruments
Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach, and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

da Vinci E-200 Generator
The da Vinci E-200 Electrosurgical Generator is intended to deliver high-frequency energy for cutting, coagulation and vessel sealing of tissues in da Vinci robotic procedures, and non-robotic open and laparoscopic procedures.

The subject da Vinci SP Surgical System’s Vision Cart replaces Erbe VIO dV generator and standalone EnergyShield Monitoring (ESM) with the da Vinci E-200 Electrosurgical Generator, which incorporates an integrated ESM.

da Vinci SP Surgical System:
The da Vinci SP Surgical System is a robotically-assisted surgical device that is designed to enable complex surgery using a minimally-invasive approach. The system consists of three major subsystems: a Surgeon Console, a Vision Cart, and a Patient Cart.

1. At the Surgeon Console, the surgeon controls all movement of the instruments and endoscope by using two hand controls and a set of foot pedals. The surgeon views the endoscope image in a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

2. The Vision Cart includes supporting electronic equipment, such as the endoscope light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the endoscope image and adjust system settings.

3. The Patient Cart is the operative component of the da Vinci SP Surgical System. It supports the positioning of the surgical port and manipulation of the surgical instruments and endoscope.

da Vinci E-200 Generator:
The da Vinci E-200 Generator is an electrosurgical unit (ESU) designed to provide high-frequency (HF) traditional monopolar, bipolar, and advanced bipolar outputs intended for cutting, coagulation and/or vessel sealing of tissues. The da Vinci E-200 Electrosurgical Generator is intended to be used with the da Vinci X, da Vinci Xi, da Vinci 5, and SP Surgical systems, and also operate as a standalone electrosurgical generator. When connected to the da Vinci surgical system, the da Vinci E-200 Generator provides HF output to da Vinci instruments. Control and status messages are passed between the da Vinci E-200 Generator and the da Vinci system through an Ethernet communication cable. The da Vinci E-200 Generator is also compatible with open and laparoscopic third-party handheld monopolar and bipolar instruments, footswitch equipped instruments (where applicable) and Intuitive auxiliary footswitch. The primary function of the da Vinci E-200 Generator is to allow a surgeon to deliver HF output to cut, seal, or coagulate tissue during surgery. The user interface includes audible indicator tones, LED indicators on the front of the generator, and status messages provided on its LCD display.

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Connected OR Hub with Device and Voice Control:
The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

SDC4K Information Management System with Device and Voice Control:
The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected devices both wired and wirelessly.

The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consist of the following components:

1. Base Console which includes:
   a. Medical Device Data System (MDDS) functionalities
   b. Optional Device Control feature
   c. Optional Voice Control feature
   d. Optional Video Image Processing (VIP) feature

2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)

3. Voice Control Package (software activation USB dongle and a wireless headset and base station)

4. Video Image Processing package (software activation USB dongle)

5. Connected OR Spoke (MDDS)

The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e., non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control and/or Voice Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices.

In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Medical Device Data System. Once the Connected OR Hub or SDC4K Information Management System Console is connected to the Spoke, Device Control and Voice Control can be extended to compatible devices which are directly connected to the Spoke. Ethernet-compatible devices are connected to the Secondary Spoke via an ethernet cable/switch.

When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm and removal of surgical smoke through a compatible insufflator.

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MiiS Horus Arthroscope:
The MiiS Horus Arthroscope is a sterile and single-use device designed for operation with its compatible display system.
It is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization of an interior cavity of the body through a surgical opening.
The device is intended for use in a hospital or medical office environment and is designed for use in adults.

MiiS Horus Endoscope Display System -Tablet:
The MiiS Horus Endoscope Display System -Tablet is intend for use with compatible endoscopes to provide visualization for endoscopic diagnosis, treatment, and video observation.

MiiS Horus Endoscope Display System -Video Box:
The MiiS Horus Endoscope Display System -Video Box is intend for use with compatible endoscopes to provide visualization for endoscopic diagnosis, treatment, and video observation.

MiiS Horus Arthroscope is a sterile and single-use device designed to be operated with its compatible display system. The device provides visualization for endoscopic procedures of an interior cavity of the body through a surgical opening.

The Arthroscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet or MiiS Horus Endoscope Display System -Video Box and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.

MiiS Horus Endoscope Display System –Tablet is a tablet which showing live image or snapshot from Arthroscope.

MiiS Horus Endoscope Display System -Video Box is a standalone imaging transfer system; it can be connected to computer to project live imaging. If needed, the pictures or videos can be storage to Tablet or computer.

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The Single Use Cytology Brush V BC-V600P-3010 is intended to be used to collect tissue specimens in the biliary system in combination with an endoscope.

BC-V600P-3010 has been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with duodenoscopes. BC-V600P-3010 is inserted into the duodenoscope through an instrument channel to reach the target area, where, by rubbing the brush on the target area, specimens or cells can be collected. BC-V600P-3010 is then withdrawn from the duodenoscope channel with the collected samples.

The handle is connected to operating wires. The grip on the handle portion controls the brush movement inside the tube. By pushing/pulling the handle, the brush at the distal end of the Subject device can be protruded from/drawn into the tube. Cells can be collected by moving over the target site with the brush.

The BC-V600P-3010 consists of:

A. Handle

• Grip: used to push to extend the brush from the tube. Pull to retract the brush back into the tube.
• Operation pipe: used to connect the grip with the wires so that it can transfer the force to push/pull the brush/distal tip.
• Locking cap: used for fixing the location of the brush by turning the locking cap clockwise.
• Injection port: Available to attach a syringe here to inject contract medium.
• Hook: attached to the boot of the endoscope or ET Control Device V (sold separately).

B. Insertion portion

• Wires: connect operation pipe with brush and distal tip to push/pull the brush from/into the tube
• Tube: works as the channel that the contrast media is injected through during use
• V marking: gives the user an approximate indication of how far the instrument has been inserted into the endoscope,
• Radiopaque marks: allow the distal end of the tube to be visualized on the X-ray monitor
• Brush: used to brush the target area to collect samples.
• Distal tip: When using a guidewire, the guidewire is inserted into the distal tip.

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