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ViSiGi® LUX is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing quide.

VISIGi® LUX is a non-sterile, single patient use device for use in gastric and bariatric surgery. It is used to apply suction, decompress the stomach, drain gastric fluids, irrigate and to serve as a sizing guide. The design is derived from the predicate by addition of battery-powered LED lights. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end includes a slide valve, integral suction regulator and a battery case. The non-rechargeable batteries power up an array of LEDs enclosed within the distal end of the tube. The purpose of the LED lights is to aid visualization of the tube by tissue transillumination during insertion and surgery under laparoscopic vision. The device is inserted by an anesthesiologist under supervision of the surgeon. The added lights do not change the intended use and are not required for the surgery to proceed safely.

The Tissue Removal System is indicated for the contained removal of tissue, including contained manual tissue sectioning, during minimally invasive surgical procedures.

The Tissue Removal System is comprised of the Tissue Removal Pouch cleared under K150781 and an additional accessory Sectioning Device. It is provided sterile, and is for single patient use. The Tissue Removal Pouch of the Tissue Removal System includes a bag with a single large opening held open by a thin, opening ring. During laparoscopic surgery, the bag is placed within the peritoneal space via an existing port site. Tissue that has been resected is placed within the bag for isolation, containment and removal from the patient. The bag opening is exteriorized. Two halves of the Tissue Removal Pouch flip ring are attached to each other and to the bag is rolled around the flip ring by inverting the flip ring, in order to draw the resected tissue toward the port site. The resected tissue is then removed en bloc (for smaller specimens), or by first dividing the specimen using the accessory Sectioning Device. The Sectioning Device is comprised of a blunt wire, a flexible passer and a handle with a blunt hook. The passer is used to encircle the specimen with the wire. The handle includes a blunt hook that can be used to aid in the advancement of the passer. The specimen is divided by the manual application of a back and forth motion to the wire. Use of the accessory Sectioning Device permits division of the specimen while maintaining the containment effectiveness of the Tissue Removal Pouch