Cleared Traditional

Omnipod GO Insulin Delivery Device

K223372 · Insulet Corporation · Chemistry
Apr 2023
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K223372 is an FDA 510(k) clearance for the Omnipod GO Insulin Delivery Device, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Insulet Corporation (Acton, US). The FDA issued a Cleared decision on April 24, 2023, 171 days after receiving the submission on November 4, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K223372 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2022
Decision Date April 24, 2023
Days to Decision 171 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LZG — Pump, Infusion, Insulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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