510(k) K223372

Omnipod GO Insulin Delivery Device by Insulet Corporation — Product Code LZG

K223372 is an FDA 510(k) premarket notification submitted by Insulet Corporation for the device "Omnipod GO Insulin Delivery Device". The FDA issued a decision of Substantially Equivalent on April 24, 2023. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Insulet Corporation has at least 10 other 510(k) clearances on record.