510(k) K112034

TECA ELITE DISPOSABLE CONCENTRIC NEEDLES by Carefusion 209, Inc. — Product Code IKT

K112034 is an FDA 510(k) premarket notification submitted by Carefusion 209, Inc. for the device "TECA ELITE DISPOSABLE CONCENTRIC NEEDLES". The FDA issued a decision of Substantially Equivalent on August 12, 2011. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Carefusion 209, Inc. has at least 4 other 510(k) clearances on record.