Nexcore GI Insufflator

Nexcore GI Insufflator is an FDA 510(k)-cleared medical device (K162332) manufactured by Nexcore Technology, 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 September 28, 2016. Regulation: 8.