510(k) K131641

MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) by Nipro Medical Corporation — Product Code FMF

K131641 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)". The FDA issued a decision of Substantially Equivalent on August 28, 2013. 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.