510(k) K102887

ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 by Percutaneous Systems, Inc. — Product Code FFL

K102887 is an FDA 510(k) premarket notification submitted by Percutaneous Systems, Inc. for the device "ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510". The FDA issued a decision of Substantially Equivalent on May 16, 2011. 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.