510(k) K023090

OPTION-VF URINARY CATHETER, FV14218 by Opticon Medical, Inc. — Product Code EZL

K023090 is an FDA 510(k) premarket notification submitted by Opticon Medical, Inc. for the device "OPTION-VF URINARY CATHETER, FV14218". The FDA issued a decision of Substantially Equivalent on March 19, 2003. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Opticon Medical, Inc. has at least 7 other 510(k) clearances on record.