510(k) K970716

OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE by Opticon Medical, Inc. — Product Code EZL

K970716 is an FDA 510(k) premarket notification submitted by Opticon Medical, Inc. for the device "OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE". The FDA issued a decision of Substantially Equivalent on May 16, 1997. 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.