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The RSH Biliary Stone Removal Device is used for endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct.

The RSH Biliary Stone Removal Device is a single-use quad lumen polyurethane balloon catheter system which can be placed with or without the need of a guide-wire. The balloon is inflated using saline with the supplied 10ml syringe. The device is equipped with two flush ports, proximal and distal to the balloon, for contrast injection. The device is provided sterile. The device is similar to the predicate device, except the balloon is polyurethane rather than latex, the fill is saline rather than air, and 4 lumens are used rather than ≤ 3 lumens. With more lumens, a somewhat larger balloon diameter range, 9 -25 mm, is achieved in one size rather than three sizes.