510(k) K162332

Nexcore GI Insufflator by Nexcore Technology, LLC — Product Code FCX

K162332 is an FDA 510(k) premarket notification submitted by Nexcore Technology, LLC for the device "Nexcore GI Insufflator". The FDA issued a decision of Substantially Equivalent on September 29, 2016. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500.