FDA 510(k)

pAguaMedicina 持續結構性水膠輸尿管支架

K 號：K163068 · 2016-12-22

決定日期2016-12-22

產品代碼FAD

諮詢委員會GU

決定相當於

器材摘要

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Q Urological Corporation. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K163068. 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 pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Q Urological Corporation. The 510(k) number is K163068.

When did pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent receive FDA 510(k) clearance?

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent received FDA 510(k) clearance on 2016-12-22, under 510(k) number K163068.

Who is the listed applicant for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

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

What is the FDA product code for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

The FDA product code for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is FAD.

其他以 Q Urological Corporation 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。

K172289pAguaMedicina 持續結構性水膠輸尿管支架

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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