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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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The Niti-S Esophageal Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

The Esophageal TTS Stents and Niti-S Esophageal Stents consist of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency. A length of suture is attached to one end of the stent and can be used for stent repositioning during initial placement, in accordance with the instructions for use.

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The Single-use Fine Needle Biopsy (FNB) device NA-U210H has been designed to be used with an ultrasound endoscope for sampling of submucosal and extramural lesions within or adjacent the gastrointestinal tract.

The Single-Use Fine Needle Biopsy (FNB) Device NA-U210H (SecureFlex) is a sterile, single-use fine needle biopsy device intended for use with an ultrasound endoscope to sample submucosal and extramural lesions within or adjacent to the gastrointestinal tract. It consists of:

• Biopsy Needle Assembly: Handle, needle (19G, 22G, or 25G), and coiled sheath.
• Aspiration System: VACLOK syringe and stopcock (FDA-cleared under K994253).

The device features a bifurcated needle tip for enhanced tissue acquisition, echo-enhanced regions for ultrasound visibility, and is compatible with Olympus GF and TGF endoscopes with ≥2.8 mm channel diameter.

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The DISPOSABLE BALLOON CATHETER B5-2Q, B7-2Q/2LA have been designed to be used with Olympus endoscopes to inject contrast medium into the biliary or pancreatic track. They can also be used for retrieval of biliary or pancreatic stones.

The Balloon Catheters are constructed of an inflatable balloon, tube, branch, injection port, air feeding port, and stopcock.

Prior to use, a sterile syringe is attached to the air feeding port and injects air into the tube to inflate the balloon to the specified volume to confirm that the balloon inflates properly. The balloon is then deflated completely, and the tube is inserted into the instrument channel of the endoscope and advanced to the target area, where the balloon is inflated to allow for biliary or pancreatic stone removal or contrast medium injection through the injection port. When the procedure is completed, the balloon is deflated and the tube is removed from the patient.

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The Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

The Single Use Sphincterotome V (Distal Wireguided) KD-VC411Q/VC431Q/VC433Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope.

The Single Use 3-Lumen Sphincterotome V KD-V411M/V431M Series is intended to be used for papillotomy using high-frequency current in combination with an endoscope and guidewire.

The DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-411Q/431Q Series is intended to be used for papillotomy using high-frequency current in combination with an endoscope.

The Single Use Sphincterotome KD-VC, KD-V, and KD Series consists of the following devices:

• Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC600 Series (aka CleverCut3V)
• Single Use Sphincterotome V (Distal Wireguided) KD-VC400 Series (aka CleverCut3V)
• Single Use 3-Lumen Sphincterotome V KD-V Series (aka CleverCut3V)
• DISPOSABLE TRIPLE Lumen SPHINCTEROTOME KD Series (aka FlowCut)

The subject devices have separate lumens for guidewire, cutting wire and injection of contrast medium for papillotomy. The knives are pre-curved and have a tapered tip to facilitate insertion into the papilla of Vater. The insertion portion of the KD-V, and KD-VC Series have a V-marking, which the relative insertion length into the endoscope can be confirmed by the positional relationship between the V-marking and the biopsy valve of the endoscope and feature an integrated C-Hook to attach to the endoscope. The distal end of the sphincterotome is coated with CleverCut coating ("Olympus' PFA (perfluoroalkoxy) coating designed to prevent thermal injury to non-target tissue while cutting the papilla of Vater. The KD-VC600 Series offers models that are preloaded with VISIGLIDE guidewires.

The subject devices are provided to the user sterilized by ethylene oxide and intended for single use only.

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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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