FDA 510(k)

EndoTool IV雲端 1.0

K 號：K260910 · 2026-05-01

決定日期2026-05-01

產品代碼NDC

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 Glooko, Inc. 為申請人之記錄

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K171450Glooko 行動式胰島素劑量系統

相關器械（代碼：NDC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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