510(k) K191359

Nipro Syringe by Nipro Medical Corporation — Product Code FMF

K191359 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "Nipro Syringe". The FDA issued a decision of Substantially Equivalent on October 9, 2019. 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.