510(k) K946243

CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER by Coloplast A/S — Product Code EXJ

K946243 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER". The FDA issued a decision of Substantially Equivalent on February 13, 1995. The device falls under product code EXJ (Device, Incontinence, Urosheath Type, Sterile), a Class I device regulated under 21 CFR 876.5250. Coloplast A/S has at least 10 other 510(k) clearances on record.