510(k) K063786

ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 by Olympus Medical Systems Corporation — Product Code FCX

K063786 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2". The FDA issued a decision of Substantially Equivalent on March 5, 2007. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.