FDA 510(k)

Entuit Start 初步放置胃造口套組

K 號：K170323 · 2017-09-14

決定日期2017-09-14

產品代碼KGC

諮詢委員會GU

決定相當於

器材摘要

Entuit Start Initial Placement Gastrostomy Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K170323. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Entuit Start Initial Placement Gastrostomy Set?

Entuit Start Initial Placement Gastrostomy Set is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Cook Incorporated. The 510(k) number is K170323.

When did Entuit Start Initial Placement Gastrostomy Set receive FDA 510(k) clearance?

Entuit Start Initial Placement Gastrostomy Set received FDA 510(k) clearance on 2017-09-14, under 510(k) number K170323.

Who is the listed applicant for Entuit Start Initial Placement Gastrostomy Set?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Entuit Start Initial Placement Gastrostomy Set?

The FDA product code for Entuit Start Initial Placement Gastrostomy Set is KGC.

其他以 Cook Incorporated 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。

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相關器械（代碼：KGC）

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。

K242211PUMA-G 小兒系統Coaptech, Inc.K223916PUMA-G 系統Coaptech, Inc.K193612AMT 緝線輸送系統Applied Medical Technology, Inc.K191844Fidmi 低配置腸內營養輸送裝置Fidmi Medical, Ltd.K182832Cope兒童腸胃縫合釘組合，造口縫合釘組合Cook Incorporated K183057PUMA-G 系統Coaptech, LLC

官方來源

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