510(k) K883886

DOUBLE CLOSED URINARY DRAINAGE SYSTEM by Knight Medical, Inc. — Product Code FCN

K883886 is an FDA 510(k) premarket notification submitted by Knight Medical, Inc. for the device "DOUBLE CLOSED URINARY DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 19, 1988. The device falls under product code FCN (Urinary Drainage Collection Kit, For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Knight Medical, Inc. has at least 4 other 510(k) clearances on record.