510(k) K221981

SafeR Syringe and SafeR Sting by Roncadelle Operations Srl — Product Code MEG

K221981 is an FDA 510(k) premarket notification submitted by Roncadelle Operations Srl for the device "SafeR Syringe and SafeR Sting". The FDA issued a decision of Substantially Equivalent on December 29, 2022. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860.