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FDA 510(k)

EZ-Protect 水性閉環系統間歇性導尿管；EZ-Protect 水性閉環系統間歇性導尿管套件

K 號：K251274 · 2026-01-29

申請人HR Healthcare
決定日期2026-01-29
產品代碼EZD
諮詢委員會GU
決定Unknown

器材摘要

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits is the device name listed in this FDA 510(k) record. The listed applicant is HR Healthcare. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K251274. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits?

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is HR Healthcare. The 510(k) number is K251274.

When did EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits receive FDA 510(k) clearance?

EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits received FDA 510(k) clearance on 2026-01-29, under 510(k) number K251274.

Who is the listed applicant for EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits?

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

What is the FDA product code for EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits?

The FDA product code for EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits is EZD.

相關臨床試驗

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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其他以 HR Healthcare 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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