510(k) K093985

NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE by Nipro Medical Corp. — Product Code FIE

K093985 is an FDA 510(k) premarket notification submitted by Nipro Medical Corp. for the device "NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE". The FDA issued a decision of Substantially Equivalent on January 22, 2010. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Nipro Medical Corp. has at least 10 other 510(k) clearances on record.