510(k) K153362

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

K153362 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "AquaShield system CO2, AquaShield system-PENTAX". The FDA issued a decision of Substantially Equivalent on December 16, 2015. 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.