FDA 510(k)

加布里埃尔3向EnFit閥

K 號：K201741 · 2020-11-05

決定日期2020-11-05

產品代碼PIF

諮詢委員會GU

決定相當於

器材摘要

Gabriel 3 Way EnFit Valve 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 2020-11-05 under 510(k) number K201741. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Gabriel 3 Way EnFit Valve?

Gabriel 3 Way EnFit Valve is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Syncro Medical Innovations, Inc.. The 510(k) number is K201741.

When did Gabriel 3 Way EnFit Valve receive FDA 510(k) clearance?

Gabriel 3 Way EnFit Valve received FDA 510(k) clearance on 2020-11-05, under 510(k) number K201741.

Who is the listed applicant for Gabriel 3 Way EnFit Valve?

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 3 Way EnFit Valve?

The FDA product code for Gabriel 3 Way EnFit Valve is PIF.

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。

K191784加百列鼻胃管配氣球，及EnFit連接器 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 GmbH K253715Edi 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 AB K254170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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