510(k) K770399

VALVE FOR CLOSED SYS. URINARY DRAINAGE by Will Ross Co. — Product Code KNX

K770399 is an FDA 510(k) premarket notification submitted by Will Ross Co. for the device "VALVE FOR CLOSED SYS. URINARY DRAINAGE". The FDA issued a decision of Substantially Equivalent on March 9, 1977. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Will Ross Co. has at least 10 other 510(k) clearances on record.