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FDA 510(k)

GERDX-系統

K 號：K233240 · 2024-06-21

申請人G-Surg GmbH
決定日期2024-06-21
產品代碼ODE
諮詢委員會GU
決定相當於

器材摘要

GERDX-System is the device name listed in this FDA 510(k) record. The listed applicant is G-Surg GmbH. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233240. 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 GERDX-System?

GERDX-System is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is G-Surg GmbH. The 510(k) number is K233240.

When did GERDX-System receive FDA 510(k) clearance?

GERDX-System received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233240.

Who is the listed applicant for GERDX-System?

The FDA 510(k) record lists G-Surg GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GERDX-System?

The FDA product code for GERDX-System 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

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。

K240879EsophyX 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.K160960EsophyX® Z 裝置搭配SerosaFuse 鍵釘及附件Endogastric Solutions, Inc.

官方來源

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