510(k) K041983

OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 by Opticon Medical — Product Code EZL

K041983 is an FDA 510(k) premarket notification submitted by Opticon Medical for the device "OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016". The FDA issued a decision of Substantially Equivalent on November 17, 2004. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Opticon Medical has at least 7 other 510(k) clearances on record.