510(k) K182258

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

K182258 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 September 21, 2018. 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.