FDA 510(k)

LumiRex 腎鏡

K 號：K243532 · 2025-04-28

決定日期2025-04-28

產品代碼FGB

諮詢委員會GU

決定相當於

器材摘要

LumiRex Ureteroscope is the device name listed in this FDA 510(k) record. The listed applicant is Contra Healthcare Solutions, LLC. It received FDA 510(k) clearance on 2025-04-28 under 510(k) number K243532. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LumiRex Ureteroscope?

LumiRex Ureteroscope is a medical device that received FDA 510(k) clearance on 2025-04-28. The listed applicant is Contra Healthcare Solutions, LLC. The 510(k) number is K243532.

When did LumiRex Ureteroscope receive FDA 510(k) clearance?

LumiRex Ureteroscope received FDA 510(k) clearance on 2025-04-28, under 510(k) number K243532.

Who is the listed applicant for LumiRex Ureteroscope?

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

What is the FDA product code for LumiRex Ureteroscope?

The FDA product code for LumiRex Ureteroscope is FGB.

其他以 Contra Healthcare Solutions, LLC 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。

K243541LumiRex 支气管鏡

相關器械（代碼：FGB）

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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