510(k) K211634

Hypodermic Needle-Pro EDGE Safety Device by Smiths Medical Asd, Inc. — Product Code FMI

K211634 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "Hypodermic Needle-Pro EDGE Safety Device". The FDA issued a decision of Substantially Equivalent on August 26, 2021. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.