510(k) K905289

SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT by Medical Engineering Corp. — Product Code FAD

K905289 is an FDA 510(k) premarket notification submitted by Medical Engineering Corp. for the device "SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT". The FDA issued a decision of Substantially Equivalent on March 13, 1991. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Medical Engineering Corp. has at least 10 other 510(k) clearances on record.