510(k) K180711

FUJIFILM Endoscopic CO2 Regulator GW-100 by Fujifilm Corporation — Product Code FCX

K180711 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "FUJIFILM Endoscopic CO2 Regulator GW-100". The FDA issued a decision of Substantially Equivalent on May 25, 2018. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Fujifilm Corporation has at least 10 other 510(k) clearances on record.