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Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space.

Applied Medical's Kii Structural Balloon Access System provides a path of entry and/or tissue retraction for laparoscopic procedures in the extraperitoneal space. The system is provided sterile.

The system is composed of four main components:

• An obturator that facilitates insertion of the system through an incision.
• A cannula with bolster and attached balloon, encased within a perforated sheath.
• A seal which maintains insufflation.
• An inflation bulb that is used to manually inflate and deflate the balloon.

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The device is intended to be used with endoscopic accessories such as a biopsy forceps and Electronic Endoscope Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

The Flexible Ureterorenoscope System consists of a sterile Flexible Ureterorenoscope and an Electronic Endoscope Image Processor with its accessories power adapter. The Flexible Ureterorenoscope is provided sterile (sterilized by EO) and is single use.

The Flexible Ureterorenoscope consists of a head section, bending section, insertion section, operating section, electrical connection section, and built-in LED light source. The Electronic Endoscope Image Processor is powered by the main line.

The Flexible Ureterorenoscope is an endoscope instrument and is intended to be used with the Electronic Endoscope Image Processor during endoscopic procedures. The handle section features several key components, including a control lever, a handle for manipulation, a button for capturing photos or video, and a Luer port for the insertion of accessories or irrigation to the working channel.

The insertion section houses a working channel and wiring to transmit the image signals to the image processor. The distal bending section of the insertion section contains a camera lens for real-time image capture, an LED light source for illumination, and a distal outlet for the working channel.

The Electronic Endoscope Image Processor is a video processor which is intended and designed for use during endoscopic procedures. It receives and processes image signals from the endoscope and outputs signals to an external medical monitor for display.

The Electronic Endoscope Image Processor has integrated software to control the operation of the device and is a reusable device that does not require sterilization before use, as there is no direct/in-direct patient contact material. The image processor is intended to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual.

The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.

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The GripTract-GI Endoscopic Tissue Manipulator (GripTract) Upper GI Model is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

GripTract Upper GI Model is indicated for use in the upper gastrointestinal tract with any standard endoscope as follows:

The GripTract-GI™ Endoscopic Tissue Manipulator (GripTract) Upper GI Model GT-GS100 is a disposable, non-sterile accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.

The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs on the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.

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Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures.

Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts.

Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Stellar Imaging System comprises Image Processing Unit, Light Source, Camera Head, Laparoscope and relevant accessories. During surgical procedures, Stellar Imaging System is used to provide real-time 3D visible and fluorescence imaging in endoscopic surgery.

The Stellar Imaging System including the laparoscope is designed to work with an approved infrared dye (Indocyanine green (ICG). ICG may be excited at excitation at either 785 or 805 nm. The System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye via the camera head. Fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow, etc.

The System allows the capture of normal (white) light image in parallel with the fluorescence image and displays both to the surgeon to provide a view of the anatomy. In addition, the System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

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The UV5000W Handle is to be used with UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V and is intended to be used to permit viewing of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics.

The UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V connect to the UV5000W Handle to become an endoscopic system that is intended to allow visualization of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics. This 510(k) discloses the modifications made to the UV5000 Handle (K250797) with the capability of transmitting the images captured wirelessly to an external monitor.

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The VereSee Optical Veres Needle and Endoscopic Camera is intended for:

• Percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic surgery

• Use as an endoscopic video camera to provide visible light imaging in a variety of endoscopic and laparoscopic diagnostic and surgical procedures

The VereSee Optical Veres Needle and Endoscopic Camera System consists of two components: 1) VereSee Optical Veres Needle and Endoscopic Camera, and 2) VereSee Camera Control Unit.

The VereSee Optical Veres Needle and Endoscopic Camera consists of a series of three concentric stainless steel cannulas with a handle and an umbilical cable to connect it to the VereSee Camera Control Unit. It is provided sterile, for single patient use. The three concentric stainless steel cannulas include: 1) an Outer Cannula (or Insufflation Cannula), 2) a Central Cannula (or Access Cannula) with a clear, pointed tip for penetration and visualization during body cavity entry, and 3) Inner Cannula (or Camera Cannula) with a CMOS camera surrounded by light fibers at its tip.

The VereSee Camera Control Unit connects the CMOS camera in the VereSee Optical Veres Needle and Endoscopic Camera to HDMI compatible monitors to provide an image for endoscopic procedures. The VereSee Camera Control Unit (CCU) includes an LED driver to power the LED. The CCU connects to the Optical Veres Needle and Endoscopic Camera via an umbilical cable. The CCU converts signals from the CMOS camera in the VereSee Optical Veres Needle and Endoscopic Camera to a format compatible with HDMI display input requirements.

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The single-use Biopsy Port Adapter (BPA) converts the biopsy/working channel port of an upper gastrointestinal endoscope into a luer-lock connector port. This adapter supports luer-lock-connector fine needle biopsy (FNB) and fine needle aspiration (FNA) devices used during an EndoSound EUS endoscopic procedure, while maintaining scope suction.

The Biopsy Port Adapter (BPA) converts the non-luer-lock biopsy/working channel port of an upper gastrointestinal endoscope into a luer-lock connector port to support Fine Needle Biopsy (FNB) and Fine Needle Aspiration (FNA) luer endoscopic procedures using luer-lock-type needles. The adapter also seals the port during use and maintains the ability of the scope to provide suction throughout the procedure. The BPA works in tandem with the EndoSound Vision System™ when performing ultrasound-guided FNA and FNB procedures.

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The Arthrex Synergy Vision imaging system is intended to provide visible light imaging in a variety of diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery.

The Arthrex Synergy Vision imaging system is indicated for use to provide real-time visible and near-infrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform open and minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex Synergy Vision imaging system is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Additionally, the system is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgical procedures.

Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex Synergy Vision imaging system is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the Arthrex Synergy Vision imaging system is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The Arthrex NanoNeedle Scope when used with the Synergy Vision imaging system is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. For pediatric patients, the Arthrex NanoNeedle Scope is indicated for laparoscopy and orthopedic procedures.

The Arthrex 4K Open Scope 0° NIR is intended to be used as an accessory with the Synergy Vision imaging system to provide visible light imaging and near-infrared fluorescence imaging during open surgical procedures.

The Synergy Vision Imaging System includes a camera control unit (CCU) console, camera head, scope, and a laser light source. The system provides real-time visible light and near-infrared (NIR) illumination and imaging.

The Synergy Vision Imaging System uses an integrated LED light to provide visible light illumination and imaging of a surgical site. For NIR imaging, the system interacts with the laser light source to visualize the presence of a fluorescence contrast agent, indocyanine green (ICG) and pafolacianine. The contrast agent fluoresces when illuminated through the scope with NIR excitation light from the laser light source and the fluorescent response is then imaged with the camera, processed, and displayed on a monitor.

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The Single Use Injector NM-400/401 Series is intended to be used to perform endoscopic vascular or submucosal injection in the digestive tract with an endoscope.

The Olympus Single-Use Injector NM-400/NM-401 is a sterile, disposable injection needle designed for use with Olympus endoscopes to perform endoscopic vascular or submucosal injections in the digestive tract. The device comprises a handle section, needle section, and sheath section, and operates via a slider mechanism that extends and retracts the needle. The needle is connected to an injection port through which fluids can be delivered to targeted tissue. The NM-400/NM-401 series includes various models with needle gauges ranging from 21G to 25G and working lengths from 1650 mm to 2700 mm, accommodating different clinical needs and endoscope compatibilities. The device is constructed from biocompatible materials including stainless steel (SUS304), polypropylene (PP), and perfluoroalkoxy (PFA), and is sterilized using ethylene oxide (EtO). It is intended for single use only.

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The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The gastroscope is a sterile single-use device and can be inserted orally or transnasally. The 110 cm gastroscope is intended to be used in adult and pediatric populations. The 85 cm gastroscope is intended to be used in the pediatric population.

The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation.

The EvoEndo Endoscopy System is comprised of three regulated components:

• EvoEndo Model LE Single-Use Gastroscope (hereafter referred to as the EvoEndo Endoscope)
• EvoEndo Reusable Video Cable (hereafter referred to as the Video Cable)
• EvoEndo Controller (hereafter referred to as the Controller)

The EvoEndo Endoscope is a sterile, single-use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of:

• Handle
• Umbilical Bundle that includes air, water, and suction lines, as well as the video connector
• Endoscope shaft with HD Camera

The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable.

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