FDA 510(k)

尿道導尿管 12 Fr，尿道導尿管 16 Fr

K 號：K211032 · 2021-11-19

決定日期2021-11-19

產品代碼KOD

諮詢委員會GU

決定相當於

器材摘要

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr is the device name listed in this FDA 510(k) record. The listed applicant is Urogen Pharma, Ltd.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K211032. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Urinary Catheter 12 Fr, Urinary Catheter 16 Fr?

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Urogen Pharma, Ltd.. The 510(k) number is K211032.

When did Urinary Catheter 12 Fr, Urinary Catheter 16 Fr receive FDA 510(k) clearance?

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr received FDA 510(k) clearance on 2021-11-19, under 510(k) number K211032.

Who is the listed applicant for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr?

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

What is the FDA product code for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr?

The FDA product code for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr is KOD.

其他以 Urogen Pharma, Ltd. 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。

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相關器械（代碼：KOD）

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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