510(k) K113422

TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE by Terumo (Philippines) Corporation — Product Code FMI

K113422 is an FDA 510(k) premarket notification submitted by Terumo (Philippines) Corporation for the device "TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE". The FDA issued a decision of Substantially Equivalent on Mar 5, 2012. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Terumo (Philippines) Corporation has 4 other 510(k) clearances on record.