510(k) K842257

CORPAK URINARY DRAINAGE BAG by Corpak Co. — Product Code KNX

K842257 is an FDA 510(k) premarket notification submitted by Corpak Co. for the device "CORPAK URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on August 8, 1984. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Corpak Co. has at least 10 other 510(k) clearances on record.