510(k) K250853

Merit Syringe by Merit Medical Systems, Inc. — Product Code FMF

K250853 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Merit Syringe". The FDA issued a decision of Substantially Equivalent on November 4, 2025. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.