FDA 510(k)

EsophyX Z, EsophyX2 HD

K 號：K172811 · 2017-10-19

決定日期2017-10-19

產品代碼ODE

諮詢委員會GU

決定相當於

器材摘要

EsophyX Z, EsophyX2 HD is the device name listed in this FDA 510(k) record. The listed applicant is Endogastric Solutions, Inc.. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K172811. The device is classified under product code ODE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EsophyX Z, EsophyX2 HD?

EsophyX Z, EsophyX2 HD is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Endogastric Solutions, Inc.. The 510(k) number is K172811.

When did EsophyX Z, EsophyX2 HD receive FDA 510(k) clearance?

EsophyX Z, EsophyX2 HD received FDA 510(k) clearance on 2017-10-19, under 510(k) number K172811.

Who is the listed applicant for EsophyX Z, EsophyX2 HD?

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

What is the FDA product code for EsophyX Z, EsophyX2 HD?

The FDA product code for EsophyX Z, EsophyX2 HD is ODE.

其他以 Endogastric Solutions, Inc. 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。

K240879EsophyX Z+ 裝置搭配SerosaFuse 鍵釘及附件 K171307EsophyX2 HD 裝置搭配 SerosaFuse 鍵釘及附件，EsophyX Z 裝置搭配 SerosaFuse 鍵釘及附件 K160960EsophyX® Z 裝置搭配SerosaFuse 鍵釘及附件

相關器械（代碼：ODE）

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。

K233240GERDX-系統G-Surg GmbH K240879EsophyX Z+ 裝置搭配SerosaFuse 鍵釘及附件Endogastric Solutions, Inc.K171307EsophyX2 HD 裝置搭配 SerosaFuse 鍵釘及附件，EsophyX Z 裝置搭配 SerosaFuse 鍵釘及附件Endogastric Solutions, Inc.K160960EsophyX® Z 裝置搭配SerosaFuse 鍵釘及附件Endogastric Solutions, Inc.

官方來源

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