FDA 510(k)

ConvertX 腎盂輸尿管支架系統

K 號：K161277 · 2016-11-22

決定日期2016-11-22

產品代碼FAD

諮詢委員會GU

決定相當於

器材摘要

ConvertX Nephroureteral Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Brightwater Medical. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K161277. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ConvertX Nephroureteral Stent System?

ConvertX Nephroureteral Stent System is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Brightwater Medical. The 510(k) number is K161277.

When did ConvertX Nephroureteral Stent System receive FDA 510(k) clearance?

ConvertX Nephroureteral Stent System received FDA 510(k) clearance on 2016-11-22, under 510(k) number K161277.

Who is the listed applicant for ConvertX Nephroureteral Stent System?

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

What is the FDA product code for ConvertX Nephroureteral Stent System?

The FDA product code for ConvertX Nephroureteral Stent System is FAD.

其他以 Brightwater Medical 為申請人之記錄

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K181669ConvertX 胆管支架系統

相關器械（代碼：FAD）

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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官方來源

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