510(k) K201936

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL by Gilero, LLC — Product Code KPE

K201936 is an FDA 510(k) premarket notification submitted by Gilero, LLC for the device "SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL". The FDA issued a decision of Substantially Equivalent on May 6, 2021. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Gilero, LLC has at least 1 other 510(k) clearance on record.