FDA 510(k)

菲格安導航 – PointerTube 直管及 PointerTube 總管

K 號：K163416 · 2017-02-16

決定日期2017-02-16

產品代碼PGW

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Fiagon Navigation – PointerTube Straight and PointerTube Keat is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K163416. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fiagon Navigation – PointerTube Straight and PointerTube Keat?

Fiagon Navigation – PointerTube Straight and PointerTube Keat is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Fiagon GmbH. The 510(k) number is K163416.

When did Fiagon Navigation – PointerTube Straight and PointerTube Keat receive FDA 510(k) clearance?

Fiagon Navigation – PointerTube Straight and PointerTube Keat received FDA 510(k) clearance on 2017-02-16, under 510(k) number K163416.

Who is the listed applicant for Fiagon Navigation – PointerTube Straight and PointerTube Keat?

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

What is the FDA product code for Fiagon Navigation – PointerTube Straight and PointerTube Keat?

The FDA product code for Fiagon Navigation – PointerTube Straight and PointerTube Keat is PGW.

其他以 Fiagon GmbH 為申請人之記錄

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相關器械（代碼：PGW）

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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