510(k) K151398

K-Pack II Needle - 29G x 5/16 Thin Wall by Terumo Europe N.V. — Product Code FMI

K151398 is an FDA 510(k) premarket notification submitted by Terumo Europe N.V. for the device "K-Pack II Needle - 29G x 5/16 Thin Wall". The FDA issued a decision of Substantially Equivalent on June 25, 2015. 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.