510(k) K223376

Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) by Cardinal Health200, LLC — Product Code MEG

K223376 is an FDA 510(k) premarket notification submitted by Cardinal Health200, LLC for the device "Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)". The FDA issued a decision of Substantially Equivalent on June 21, 2023. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Cardinal Health200, LLC has at least 10 other 510(k) clearances on record.