510(k) K090879

INSUFLOW CO2IONSHIELD by Lexion Medical, LLC — Product Code FCX

K090879 is an FDA 510(k) premarket notification submitted by Lexion Medical, LLC for the device "INSUFLOW CO2IONSHIELD". The FDA issued a decision of Substantially Equivalent on July 23, 2009. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Lexion Medical, LLC has at least 10 other 510(k) clearances on record.