FDA 510(k)

EndoTool IV Cloud 1.0

K-Number: K260910 · 2026-05-01

Decision Date2026-05-01

Product CodeNDC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

EndoTool IV Cloud 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Glooko, Inc.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K260910. 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 EndoTool IV Cloud 1.0?

EndoTool IV Cloud 1.0 is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Glooko, Inc.. The 510(k) number is K260910.

When did EndoTool IV Cloud 1.0 receive FDA 510(k) clearance?

EndoTool IV Cloud 1.0 received FDA 510(k) clearance on 2026-05-01, under 510(k) number K260910.

Who is the listed applicant for EndoTool IV Cloud 1.0?

The FDA 510(k) record lists Glooko, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoTool IV Cloud 1.0?

The FDA product code for EndoTool IV Cloud 1.0 is NDC.

Other records listing Glooko, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171450Glooko Mobile Insulin Dosing System

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Official Source

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