FDA 510(k)

Endomina EZFuse系統

K 號：K252400 · 2026-02-13

決定日期2026-02-13

產品代碼OCW

諮詢委員會GU

決定相當於

器材摘要

Endomina EZFuse system is the device name listed in this FDA 510(k) record. The listed applicant is Endo Tools Therapeutics S.A.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K252400. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endomina EZFuse system?

Endomina EZFuse system is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Endo Tools Therapeutics S.A.. The 510(k) number is K252400.

When did Endomina EZFuse system receive FDA 510(k) clearance?

Endomina EZFuse system received FDA 510(k) clearance on 2026-02-13, under 510(k) number K252400.

Who is the listed applicant for Endomina EZFuse system?

The FDA 510(k) record lists Endo Tools Therapeutics S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endomina EZFuse system?

The FDA product code for Endomina EZFuse system is OCW.

其他以 Endo Tools Therapeutics S.A. 為申請人之記錄

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K211309endomina系統

相關器械（代碼：OCW）

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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