510(k) K132233

K-PACK II NEEDLE - 27G X 3/4 THIN WALL by Terumo Europe N.V. — Product Code FMI

K132233 is an FDA 510(k) premarket notification submitted by Terumo Europe N.V. for the device "K-PACK II NEEDLE - 27G X 3/4 THIN WALL". The FDA issued a decision of Substantially Equivalent on September 6, 2013. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Terumo Europe N.V. has at least 10 other 510(k) clearances on record.