510(k) K250658

SureFine Pen Needle by Shina Med Corporation — Product Code FMI

K250658 is an FDA 510(k) premarket notification submitted by Shina Med Corporation for the device "SureFine Pen Needle". The FDA issued a decision of Substantially Equivalent on April 3, 2025. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Shina Med Corporation has at least 6 other 510(k) clearances on record.