510(k) K110527

K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE by Terumo Europe N.V. — Product Code FMI

K110527 is an FDA 510(k) premarket notification submitted by Terumo Europe N.V. for the device "K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE". The FDA issued a decision of Substantially Equivalent on June 6, 2011. 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.