510(k) K252279

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) by Chirana T.Injecta,A.S. — Product Code FMF

K252279 is an FDA 510(k) premarket notification submitted by Chirana T.Injecta,A.S. for the device "Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)". The FDA issued a decision of Substantially Equivalent on April 17, 2026. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Chirana T.Injecta,A.S. has at least 1 other 510(k) clearance on record.