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FDA 510(k)

EsophyX® Z 裝置搭配SerosaFuse 鍵釘及附件

K 號：K160960 · 2016-05-01

申請人Endogastric Solutions, Inc.
決定日期2016-05-01
產品代碼ODE
諮詢委員會GU
決定相當於

器材摘要

EsophyX® Z Device with SerosaFuse Fasteners and Accessories 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 2016-05-01 under 510(k) number K160960. 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 Device with SerosaFuse Fasteners and Accessories?

EsophyX® Z Device with SerosaFuse Fasteners and Accessories is a medical device that received FDA 510(k) clearance on 2016-05-01. The listed applicant is Endogastric Solutions, Inc.. The 510(k) number is K160960.

When did EsophyX® Z Device with SerosaFuse Fasteners and Accessories receive FDA 510(k) clearance?

EsophyX® Z Device with SerosaFuse Fasteners and Accessories received FDA 510(k) clearance on 2016-05-01, under 510(k) number K160960.

Who is the listed applicant for EsophyX® Z Device with SerosaFuse Fasteners and Accessories?

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 Device with SerosaFuse Fasteners and Accessories?

The FDA product code for EsophyX® Z Device with SerosaFuse Fasteners and Accessories is ODE.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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K172811EsophyX Z, EsophyX2 HDK171307EsophyX2 HD 裝置搭配 SerosaFuse 鍵釘及附件，EsophyX 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 GmbHK240879EsophyX Z+ 裝置搭配SerosaFuse 鍵釘及附件Endogastric Solutions, Inc.K172811EsophyX Z, EsophyX2 HDEndogastric 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.

官方來源

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