510(k) K933941

MENLO CARE URINARY DIVERSION STENT by Menlo Care, Inc. — Product Code FAD

K933941 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "MENLO CARE URINARY DIVERSION STENT". The FDA issued a decision of Substantially Equivalent on March 31, 1994. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Menlo Care, Inc. has at least 10 other 510(k) clearances on record.