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FDA 510(k)

UroLift 2 系統（原名 UL500），UroLift 2 射入把手，UroLift 2 培養藥劑

K 號：K201837 · 2020-07-31

申請人Neotract, Inc.
決定日期2020-07-31
產品代碼PEW
諮詢委員會GU
決定相當於

器材摘要

UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K201837. The device is classified under product code PEW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge?

UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Neotract, Inc.. The 510(k) number is K201837.

When did UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge receive FDA 510(k) clearance?

UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201837.

Who is the listed applicant for UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge?

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

What is the FDA product code for UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge?

The FDA product code for UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge is PEW.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Neotract, Inc. 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。

K232558UroLift 2 ATC 高級組織控制系統K212396UroLift 系統硬式回收套件消毒托盤K200441UroLift先進組織控制（ATC）系統K192781UroLift 系統手術套件 遮菌托盤K193269UroLift 系統 (UL400)K190377UroLift 系統 UL400

查看所有 11 項裝置 →

相關器械（代碼：PEW）

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。

K232558UroLift 2 ATC 高級組織控制系統Neotract, Inc.K200441UroLift先進組織控制（ATC）系統Neotract, Inc.K193269UroLift 系統 (UL400)Neotract, Inc.K190377UroLift 系統 UL400Neotract, Inc.K173087UroLift 系統（UL400 和 UL500）Neotract, Inc.K172359UroLift 系統 (UL500)Neotract, Inc.

官方來源

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