FDA 510(k)

EndoFLIP

K 號：K160725 · 2016-05-01

決定日期2016-05-01

產品代碼FFX

諮詢委員會GU

決定相當於

器材摘要

EndoFLIP is the device name listed in this FDA 510(k) record. The listed applicant is Crospon, Ltd.. It received FDA 510(k) clearance on 2016-05-01 under 510(k) number K160725. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndoFLIP?

EndoFLIP is a medical device that received FDA 510(k) clearance on 2016-05-01. The listed applicant is Crospon, Ltd.. The 510(k) number is K160725.

When did EndoFLIP receive FDA 510(k) clearance?

EndoFLIP received FDA 510(k) clearance on 2016-05-01, under 510(k) number K160725.

Who is the listed applicant for EndoFLIP?

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

What is the FDA product code for EndoFLIP?

The FDA product code for EndoFLIP is FFX.

其他以 Crospon, Ltd. 為申請人之記錄

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。

K183072EndoFLIP系統 K172128EsoFLIP® ES-310 气球導管 K170833EndoFLIP® 系統搭配 FLIP 地形模組

相關器械（代碼：FFX）

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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