Gastro Concepts Air Assist

Gastro Concepts Air Assist is an FDA 510(k)-cleared medical device (K242668) manufactured by Gastro Concepts, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2024. Regulation: 8.