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FDA 510(k)

PUMA-G 系統

K 號：K183057 · 2019-04-10

申請人Coaptech, LLC
決定日期2019-04-10
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, LLC. It received FDA 510(k) clearance on 2019-04-10 under 510(k) number K183057. 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 2019-04-10. The listed applicant is Coaptech, LLC. The 510(k) number is K183057.

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

PUMA-G System received FDA 510(k) clearance on 2019-04-10, under 510(k) number K183057.

Who is the listed applicant for PUMA-G System?

The FDA 510(k) record lists Coaptech, LLC 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.

相關臨床試驗

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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

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 IncorporatedK170323Entuit Start 初步放置 胃造口套組Cook Incorporated

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