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The EndoVive™ Low Profile Replacement Gastrostomy Tube is indicated in adult and pediatric populations for use in percutaneous placement of an Enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. The replacement tube may also be used for decompression.

The EndoVive™ Low Profile Replacement GastrostomyTube is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using a silicone RTV. The shaft is filled with a radiopague barium RTV. In use, the balloon end of the catheter is inserted into an established stoma, the balloon inflated with 3 mL saline, and the bolster slide down to the skin to secure the device in place. There are two versions of the bolster, a straight version and a right angle

This urological catheter is intended for the infusion of Sterile solution into the b ladder to irrigate, cleanse, or drain thecontents of the bladder during surgical procedures.

Both the device in this submission and the predicate device are used to irrigate and drain the bladder. Both devices use an inflation balloon to retain the Catheter in the bladder. Both devices are 3-way foley Catheters.