510(k) K013921

PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X by Porges S.A. — Product Code FAD

K013921 is an FDA 510(k) premarket notification submitted by Porges S.A. for the device "PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X". The FDA issued a decision of Substantially Equivalent on October 17, 2002. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Porges S.A. has at least 10 other 510(k) clearances on record.