510(k) K212095

SurGuard3 Safety Hypodermic Needle by Terumo Europe N.V. — Product Code FMI

K212095 is an FDA 510(k) premarket notification submitted by Terumo Europe N.V. for the device "SurGuard3 Safety Hypodermic Needle". The FDA issued a decision of Substantially Equivalent on August 22, 2022. 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.