510(k) K133976

FUJIFILM ENDOSCOPIC CO2 REGULATOR by Fujifilm Medical System U.S.A., Inc. — Product Code FCX

K133976 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FUJIFILM ENDOSCOPIC CO2 REGULATOR". The FDA issued a decision of Substantially Equivalent on September 9, 2014. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.