ReShape Lifesciences Gets 510(k) Clearance for Gastro Intestinal Balloon Indicator

San Clemente, Calif.-based ReShape Lifesciences has received FDA’s 510(k) clearance for its disposable Gastro Intestinal Balloon Indicator calibration tubes for use in gastric and bariatric surgical procedures.

The devices are available in three sizes and can be used in a variety of procedures, including laparoscopic gastrectomy and gastric bypass surgeries.

The newly cleared tubes include a balloon feature that helps bariatric surgeons “better visualize the anatomy, making it easier to identify potential defects,” the company said.

ReShape Lifesciences develops products that manage and treat obesity and metabolic disease. The company plans to launch the Gastro calibration tubes in September.