510(k) K230718

UTC 3mL Medication Cartridge by Gilero, LLC — Product Code MRZ

K230718 is an FDA 510(k) premarket notification submitted by Gilero, LLC for the device "UTC 3mL Medication Cartridge". The FDA issued a decision of Substantially Equivalent on June 15, 2023. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Gilero, LLC has at least 1 other 510(k) clearance on record.