510(k) K191559

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM by United States Endoscopy Group, Inc. — Product Code FEQ

K191559 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM". The FDA issued a decision of Substantially Equivalent on August 1, 2019. 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.