510(k) K960148

CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT by Cabot Medical Corp. — Product Code FAD

K960148 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT". The FDA issued a decision of Substantially Equivalent on March 25, 1996. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.