510(k) K082803

COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 by Percutaneous Systems, Inc. — Product Code FFL

K082803 is an FDA 510(k) premarket notification submitted by Percutaneous Systems, Inc. for the device "COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015". The FDA issued a decision of Substantially Equivalent on November 13, 2008. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Percutaneous Systems, Inc. has at least 5 other 510(k) clearances on record.