510(k) K052048

ACCORDION by Percutaneous Systems, Incorporated — Product Code FFL

K052048 is an FDA 510(k) premarket notification submitted by Percutaneous Systems, Incorporated for the device "ACCORDION". The FDA issued a decision of Substantially Equivalent on September 13, 2005. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Percutaneous Systems, Incorporated has at least 4 other 510(k) clearances on record.