510(k) K971764

WELCON HUE-VU URINARY DRAINAGE BAG by Welcon, Inc. — Product Code KNX

K971764 is an FDA 510(k) premarket notification submitted by Welcon, Inc. for the device "WELCON HUE-VU URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on July 29, 1997. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Welcon, Inc. has at least 7 other 510(k) clearances on record.