FDA 510(k)

一次性經皮腎盂穿刺擴張套件

K 號：K250448 · 2025-07-03

申請人Shenzhen Trious Medical Technology Co., Ltd.

決定日期2025-07-03

產品代碼LJE

決定相當於

器材摘要

Disposable Percutaneous Nephrostomy Dilatation Kit is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Trious Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K250448. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Percutaneous Nephrostomy Dilatation Kit?

Disposable Percutaneous Nephrostomy Dilatation Kit is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Shenzhen Trious Medical Technology Co., Ltd.. The 510(k) number is K250448.

When did Disposable Percutaneous Nephrostomy Dilatation Kit receive FDA 510(k) clearance?

Disposable Percutaneous Nephrostomy Dilatation Kit received FDA 510(k) clearance on 2025-07-03, under 510(k) number K250448.

Who is the listed applicant for Disposable Percutaneous Nephrostomy Dilatation Kit?

The FDA 510(k) record lists Shenzhen Trious Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Percutaneous Nephrostomy Dilatation Kit?

The FDA product code for Disposable Percutaneous Nephrostomy Dilatation Kit is LJE.

其他以 Shenzhen Trious Medical Technology Co., 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：LJE）

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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