510(k) K981489

UROSURGE SPIRASTENT PLUS URETERAL STENT by Urosurge, Inc. — Product Code FAD

K981489 is an FDA 510(k) premarket notification submitted by Urosurge, Inc. for the device "UROSURGE SPIRASTENT PLUS URETERAL STENT". The FDA issued a decision of Substantially Equivalent on May 29, 1998. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Urosurge, Inc. has at least 3 other 510(k) clearances on record.