FDA 510(k)

Omnipod GO Insulin Delivery Device

K-Number: K223372 · 2023-04-24

Decision Date2023-04-24

Product CodeLZG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Omnipod GO Insulin Delivery Device is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2023-04-24 under approval number K223372. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnipod GO Insulin Delivery Device?

Omnipod GO Insulin Delivery Device is a medical device that received FDA 510(k) clearance on 2023-04-24. It is manufactured by Insulet Corporation. The 510(k) number is K223372.

When was Omnipod GO Insulin Delivery Device approved by the FDA?

Omnipod GO Insulin Delivery Device received FDA 510(k) clearance on 2023-04-24, under approval number K223372.

What company makes Omnipod GO Insulin Delivery Device?

Omnipod GO Insulin Delivery Device is manufactured by Insulet Corporation.

What is the FDA product code for Omnipod GO Insulin Delivery Device?

The FDA product code for Omnipod GO Insulin Delivery Device is LZG.

Related Clinical Trials

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Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025) PMID: 40553217 Device reps in theatre: blurred boundaries or regulatory gaps? Monash bioethics review (2025) PMID: 39855465 [Review of practices concerning the delivery of an international implant card following the implantation of a medical device]. Annales pharmaceutiques francaises (2025)

Other Devices by Insulet Corporation

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Related Devices (Code: LZG)

K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160252OmniPod Insulin Management SystemInsulet Corporation K162296OmniPod Insulin Management SystemInsulet Corporation K180045Omnipod DASH Insulin Management SystemInsulet Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.