FDA 510(k)

EndoTool IV Cloud 1.0

K号: K260910 · 2026-05-01

决定日期2026-05-01

产品代码NDC

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决定实质等同

器械摘要

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.

常见问题

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.

列明Glooko, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K171450Glooko 移动胰岛素剂量系统

官方来源

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