FDA 510(k)

SureCath 設備

K 號：K242049 · 2024-11-26

決定日期2024-11-26

產品代碼EZD

諮詢委員會GU

決定相當於

器材摘要

SureCath Set is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K242049. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SureCath Set?

SureCath Set is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Coloplast Corp.. The 510(k) number is K242049.

When did SureCath Set receive FDA 510(k) clearance?

SureCath Set received FDA 510(k) clearance on 2024-11-26, under 510(k) number K242049.

Who is the listed applicant for SureCath Set?

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

What is the FDA product code for SureCath Set?

The FDA product code for SureCath Set is EZD.

其他以 Coloplast Corp. 為申請人之記錄

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相關器械（代碼：EZD）

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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