510(k) K961248

BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS by C.R. Bard, Inc. — Product Code FFL

K961248 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS". The FDA issued a decision of Substantially Equivalent on May 28, 1996. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.