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The Single Use Retrieval Basket V FG-V421PR/FG-V422PR/FG-V431P/FG-V432P are intended to be used to retrieve stones from the biliary tract in combination with an endoscope.

The Single Use Retrieval Basket V Series is comprised of four (4), sterile, single-use, retrieval baskets designed to retrieve stones from the biliary tract. The retrieval baskets, manufactured from stainless steel, are provided as an 8-wire or 4-wire type. Each device has two sections: the handle and the insertion. The grip of the handle is used to control and operate the retrieval basket. The insertion, consisting of the sheath and the retrieval basket, is introduced into the biliary tract through an endoscope. The subject devices are intended to be used with Olympus endoscopes featuring a working length of less than 1400 mm (model: TJF) and a channel inner diameter of Ø 4.2 mm. The Olympus Lithotriptor (model BML-110A-1 or BML-610A) may be used in case of an emergency. Legally marketed Olympus guidewires (outer diameter Ø 0.89 mm) may be used with the Single Use Retrieval Basket V FG-V431P and FG-V432P models.

This device is used for the endoscopic removal of stones in the biliary system and foreign bodies.

The proposed device is a sterile, single-use accessory to be used with endoscopic, intended to be used for the removal of stones in the biliary system and foreign bodies. The proposed device includes two types, one type (Hereinafter referred to Type 1) is working through the channel provided by duodenoscopy, cross the duodenal papilla and insert into the bile duct, with the assistance of Imaging field of view formed by X-ray, capture and remove stones out of bile duct. Another one (Hereinafter referred to Type 2) is working through the channel provided by choledochoscope, after the choledochoscope was inserted into the bile duct successfully, inserted the extraction basket into the bile duct by the channel of choledochoscope, capture and remove stones out of bile duct by the direct field view of choledochoscope. The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 1 year for Type 1 and 3 years for Type 2.

The Single-use Extraction Baskets is intended for the endoscopic removal of stones and stone fragments in the biliary system.

The Single-use Extraction Baskets is a single-use, sterile, disposable device. It is intended for the endoscopic removal of stones and stone fragments in the biliary system. The device consists of basket, sheath, and handle components. The basket component is constructed of stainless steel/nitinol wires. And the basket is connected to the handle of the operating portion through the insertion portion. Activating the handle allows the basket to open or close. This device is not compatible with any mechanical lithotripter.

Endoscopic removal of stones in the biliary system and foreign bodies.

The Stone Extraction Baskets is a sterile, single use device compatible with the accessory channel of endoscopes (Minimum Endoscope Channel Inner Diameter: 2mm and 2.8mm). Diameters of Outer Tube of the device are 1.8mm and 2.3mm, working lengths are 700mm,200mm and 2300mm, and open widths are 10mm, 15mm, 20mm,35mm,40mm, and the devices have eight types of baskets and two kinds of handles (single hand type and two hands type). It is comprised of guiding head (stainless steel/nitinol), pulling wire (stainless steel), outer tube(PTFE) and handle components (ABS, stainless steel and etc.). Basket is advanced out of and retracted into the polytetrafluoroethylene outer tube using the handle. The device is not compatible with any mechanical lithotripter.

The SpyGlass Discover Retrieval Basket is indicated for the endoscopic removal of stones and stone fragments in the biliary system.

The SpyGlass Discover Retrieval Basket is designed to be used with the SpyGlass Discover Digital Catheter (K200483), which is a single-use endoscope. The SpyGlass Discover Retrieval Basket is a self-expanding nitinol wire basket that is housed within a flexible sheath. The basket is extended from the sheath (opened) and retracted into the sheath (closed) using a thumb slide on the proximal handle. The basket cage is made of four nitinol wire legs. The basket wires are looped at the distal end featuring a tipless design with no exposed wire ends.

The device is used for the endoscopic removal of biliary stones and foreign bodies.

The subject Disposable Stone Extraction Basket is comprised of a stainless steel/nitinol basket at the distal end of a sheath with handle. Basket is advanced out of and retracted into the single lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter. EO Sterilization and use for single use only.

The Stonetome Stone Removal Device is indicated for use in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP), transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.

The Stonetome Stone Removal Device is a 200 cm tapered 7F (2.3 mm) to 5.5F (1.8 mm) triple lumen catheter that incorporates a sphincterotome with a latex retrieval balloon. The Stonetome Stone Removal Device is available in several configurations: (1) with the latex balloon mounted distal or proximal to the cutting wire, (2) with a 20- or 30-mm wire, and (3) with a 5 mm or 20 mm distal tip.

Used for endoscopic removal of biliary stones, pancreatic stones, and foreign bodies.

The Wilson-Cook Mini Basket Extraction Basket is a sterile, single use device used through the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament metal wires and a helical design. The catheter is 200 cm in total length with a working length of 182 cm and 5 Fr diameter. The catheter is composed of Polytetrafluoroethylene (PTFE). The handle is a pin-vice design composed of polycarbonate with an acetal side arm fitting. The device is not compatible with any mechanical lithotripter.

Endoscopic removal of stones in the biliary system and foreign bodies.

The Non-Lithotripsy Extraction Basket is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament or multifilament metal wires joined at the distal and proximal ends, and is advanced out of and retracted into the single or double lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter.

The Nathanson Transcystic Bile Duct Stone Exploration Pack is intended for extraction of bile duct stones via laparoscopic transcystic approach.

The Nathanson Transcystic Bile Duct Stone Exploration Pack is a pre-assembled device comprising of a cholangiography catheter, a flatwire stone basket, "Y" Tuohy-Borst adapter, and a connecting tube assembly with a stopcock. The device is used in a healthcare facility/hospital environment during common bile duct exploration procedures. The subject device requires a transcystic surgical approach by a clinician for the removal of bile duct stones. When complete removal of common bile duct stones cannot be achieved, alternative approaches such as endoscopic retrograde cholangiography with sphincterotomy (ERCP) may be considered. The subject device is provided sterile and for single-use only.