510(k) K220890

IO Needle Safety Sheath by Actuated Medical, Inc. — Product Code FMI

K220890 is an FDA 510(k) premarket notification submitted by Actuated Medical, Inc. for the device "IO Needle Safety Sheath". The FDA issued a decision of Substantially Equivalent on October 31, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Actuated Medical, Inc. has at least 9 other 510(k) clearances on record.