510(k) K212677

aboNT SYRINGE by Nipro Medical Corporation — Product Code FMF

K212677 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "aboNT SYRINGE". The FDA issued a decision of Substantially Equivalent on April 15, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.