510(k) K801629

COVER-ALL MALE INCONTINENCE DEVICE by The Urology Group — Product Code KNX

K801629 is an FDA 510(k) premarket notification submitted by The Urology Group for the device "COVER-ALL MALE INCONTINENCE DEVICE". The FDA issued a decision of Substantially Equivalent on August 12, 1980. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. The Urology Group has at least 5 other 510(k) clearances on record.