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FDA 510(k)

CystoSure Plus 尿管

K 號：K181346 · 2018-08-06

申請人Emmy Medical, LLC
決定日期2018-08-06
產品代碼EZL
諮詢委員會GU
決定相當於

器材摘要

CystoSure Plus Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Emmy Medical, LLC. It received FDA 510(k) clearance on 2018-08-06 under 510(k) number K181346. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CystoSure Plus Catheter?

CystoSure Plus Catheter is a medical device that received FDA 510(k) clearance on 2018-08-06. The listed applicant is Emmy Medical, LLC. The 510(k) number is K181346.

When did CystoSure Plus Catheter receive FDA 510(k) clearance?

CystoSure Plus Catheter received FDA 510(k) clearance on 2018-08-06, under 510(k) number K181346.

Who is the listed applicant for CystoSure Plus Catheter?

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

What is the FDA product code for CystoSure Plus Catheter?

The FDA product code for CystoSure Plus Catheter is EZL.

相關臨床試驗

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相關器械（代碼：EZL）

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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