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FDA 510(k)

MiniMed Go App

K-Number: K253512 · 2026-01-08

ApplicantMedtronic Minimed
Decision Date2026-01-08
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MiniMed Go App is a medical device manufactured by Medtronic Minimed. It received FDA 510(k) clearance on 2026-01-08 under approval number K253512. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiniMed Go App?

MiniMed Go App is a medical device that received FDA 510(k) clearance on 2026-01-08. It is manufactured by Medtronic Minimed. The 510(k) number is K253512.

When was MiniMed Go App approved by the FDA?

MiniMed Go App received FDA 510(k) clearance on 2026-01-08, under approval number K253512.

What company makes MiniMed Go App?

MiniMed Go App is manufactured by Medtronic Minimed.

What is the FDA product code for MiniMed Go App?

The FDA product code for MiniMed Go App is NDC.

Related Clinical Trials

NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

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Related Devices (Code: NDC)

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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.

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