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FDA 510(k)

加百列鼻胃管配氣球，及EnFit連接器

K 號：K191784 · 2019-11-15

申請人Syncro Medical Innovations, Inc.
決定日期2019-11-15
產品代碼PIF
諮詢委員會GU
決定Unknown

器材摘要

Gabriel Feeding Tube with Balloon, and EnFit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Syncro Medical Innovations, Inc.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K191784. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the Gabriel Feeding Tube with Balloon, and EnFit Connector?

Gabriel Feeding Tube with Balloon, and EnFit Connector is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Syncro Medical Innovations, Inc.. The 510(k) number is K191784.

When did Gabriel Feeding Tube with Balloon, and EnFit Connector receive FDA 510(k) clearance?

Gabriel Feeding Tube with Balloon, and EnFit Connector received FDA 510(k) clearance on 2019-11-15, under 510(k) number K191784.

Who is the listed applicant for Gabriel Feeding Tube with Balloon, and EnFit Connector?

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

What is the FDA product code for Gabriel Feeding Tube with Balloon, and EnFit Connector?

The FDA product code for Gabriel Feeding Tube with Balloon, and EnFit Connector is PIF.

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 Syncro Medical Innovations, 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。

K201741加布里埃尔3向EnFit閥K160787加百列鼻胃管，帶氣囊磁導鼻胃管，加百列鼻胃管，預裝針筒

相關器械（代碼：PIF）

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。

K260110danumed 食道造口按鈕擴充組Danumed Medizintechnik GmbHK253715Edi 尿管 ENFit 6Fr/48 cm (6893166)；Edi 尿管 ENFit 6Fr/49cm (6893273)；Edi 尿管 ENFit 6Fr/50cm (6893274)；Edi 尿管 ENFit 8Fr/50cm (6893275)；Edi 尿管 ENFit 8Fr/100cm (6893276)；Edi 尿管 ENFit 8Fr/125cm (6893277)；Edi 尿管 ENFit 12Fr/125cm (6893278)；Edi 尿管 ENFit 16Fr/125cm (6893279)Maquet Critical Care ABK254170經皮內視鏡胃造口術（PEG）套件Degania Silicone , Ltd.K242917腸內引流系統，腸內藥劑吸管HMC Premedical S.p.A.K250481延伸喂食設備搭配ENFit™連接器SKY Medical, a.s.K240052一次性腸內營養輸注套組Beijing L&Z Medical Technology Development Co., Ltd.

官方來源

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