510(k) K091767

3 WAY SILICONE FOLEY BALLOON CATHETER by Cook Urological, Inc. — Product Code EZL

K091767 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "3 WAY SILICONE FOLEY BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on October 9, 2009. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.