FDA 510(k)

PUMA-G 系統

K 號：K223916 · 2023-03-29

決定日期2023-03-29

產品代碼KGC

諮詢委員會GU

決定相當於

器材摘要

PUMA-G System is the device name listed in this FDA 510(k) record. The listed applicant is Coaptech, Inc.. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K223916. 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 PUMA-G System?

PUMA-G System is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Coaptech, Inc.. The 510(k) number is K223916.

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

PUMA-G System received FDA 510(k) clearance on 2023-03-29, under 510(k) number K223916.

Who is the listed applicant for PUMA-G System?

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

What is the FDA product code for PUMA-G System?

The FDA product code for PUMA-G System is KGC.

其他以 Coaptech, 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。

K242211PUMA-G 小兒系統

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

官方來源

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