FDA 510(k)

AMT 緝線輸送系統

K 號：K193612 · 2020-03-12

決定日期2020-03-12

產品代碼KGC

諮詢委員會GU

決定相當於

器材摘要

AMT Suture Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K193612. 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 AMT Suture Delivery System?

AMT Suture Delivery System is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K193612.

When did AMT Suture Delivery System receive FDA 510(k) clearance?

AMT Suture Delivery System received FDA 510(k) clearance on 2020-03-12, under 510(k) number K193612.

Who is the listed applicant for AMT Suture Delivery System?

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

What is the FDA product code for AMT Suture Delivery System?

The FDA product code for AMT Suture Delivery System is KGC.

其他以 Applied Medical Technology, 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。

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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.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 K170323Entuit Start 初步放置胃造口套組Cook Incorporated

官方來源

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