INSUFLOW CO2IONSHIELD

INSUFLOW CO2IONSHIELD is an FDA 510(k)-cleared medical device (K090879) manufactured by Lexion Medical, 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 July 22, 2009. Regulation: 8.