510(k) K090485

COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 by Percutaneous Systems, Incorporated — Product Code LQR

K090485 is an FDA 510(k) premarket notification submitted by Percutaneous Systems, Incorporated for the device "COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003". The FDA issued a decision of Substantially Equivalent on July 22, 2009. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Percutaneous Systems, Incorporated has at least 4 other 510(k) clearances on record.