FDA Clears Gastro Concepts’ Air Assist Device

Gastro Concepts has won U.S. Food and Drug Administration (FDA) 510(k) clearance for its Air Assist device, a disposable product designed to prevent air and carbon dioxide (CO₂) escape during a colonoscopy, thereby maintaining colonic distension for enhanced visibility and more efficient procedures.

Developed by a practicing gastroenterologist with extensive endoscopic experience, the Air Assist addresses a common issue encountered during colonoscopy. This solution promises to improve the colonoscopy experience for both endoscopists and support staff, according to the company. The device, made of self-lubricating medical-grade silicone, is easy to use and maneuver. It forms a reversible seal between the colonoscope and the anus or stoma, allowing for on-demand colonic distension that can be controlled by either the endoscopist or the technician.

“We are thrilled to bring this innovative device to the market,” Gastro Concepts Chief Medical Officer Dr. Jason Slate said. “The Air Assist will not only simplify the procedure but also enhance patient outcomes by providing superior visibility during both diagnostic and therapeutic colonoscopy.”

The Air Assist is designed for single use, ensuring safety and convenience, and aims to set a new standard in colonoscopy procedures by reducing frustration and improving efficiency. Gastro Concepts develops solutions that elevate the practice of gastroenterology, and the FDA clearance of the Air Assist marks a significant milestone in that mission.

Gastro Concepts is a team of a gastroenterologists and engineers, dedicated to finding improvements and enhancing the safety and efficacy in gastroenterology. The Air Assist was developed by a practicing gastroenterologist with extensive endoscopic experience, who after years of performing thousands of colonoscopies, found a simple safe solution to a common problem.