510(k) K120123

AQUASHIELD CO2 SYSTEM by United States Endoscopy Group, Inc. — Product Code FEQ

K120123 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "AQUASHIELD CO2 SYSTEM". The FDA issued a decision of Substantially Equivalent on March 28, 2012. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.