510(k) K131249

ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES by I-Flow, LLC — Product Code MEB

K131249 is an FDA 510(k) premarket notification submitted by I-Flow, LLC for the device "ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES". The FDA issued a decision of Substantially Equivalent on February 3, 2014. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. I-Flow, LLC has at least 10 other 510(k) clearances on record.