510(k) K821848

ASSURE-MALE EXTERNAL INCONTINCE CATHETER by Medical Design & Manufacturing Corp. — Product Code KNX

K821848 is an FDA 510(k) premarket notification submitted by Medical Design & Manufacturing Corp. for the device "ASSURE-MALE EXTERNAL INCONTINCE CATHETER". The FDA issued a decision of Substantially Equivalent on August 10, 1982. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Medical Design & Manufacturing Corp. has at least 9 other 510(k) clearances on record.