510(k) K915246

CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) by Coloplast A/S — Product Code EXI

K915246 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)". The FDA issued a decision of Substantially Equivalent on February 5, 1992. The device falls under product code EXI (Device, Paste-On For Incontinence, Sterile), a Class I device regulated under 21 CFR 876.5250. Coloplast A/S has at least 10 other 510(k) clearances on record.