510(k) K052440

MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER by Mentor Corporation — Product Code EZD

K052440 is an FDA 510(k) premarket notification submitted by Mentor Corporation for the device "MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER". The FDA issued a decision of Substantially Equivalent on October 11, 2005. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Mentor Corporation has at least 3 other 510(k) clearances on record.