FDA 510(k)

UroLift 系統 UL500，UroLift 輸送把手，UroLift 傾入式藥劑盒

K 號：K162345 · 2016-09-21

決定日期2016-09-21

產品代碼PEW

諮詢委員會GU

決定相當於

器材摘要

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K162345. 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 System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Neotract, Inc.. The 510(k) number is K162345.

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

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge received FDA 510(k) clearance on 2016-09-21, under 510(k) number K162345.

Who is the listed applicant for UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?

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 System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?

The FDA product code for UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is PEW.

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 K201837UroLift 2 系統（原名 UL500），UroLift 2 射入把手，UroLift 2 培養藥劑 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)

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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.K201837UroLift 2 系統（原名 UL500），UroLift 2 射入把手，UroLift 2 培養藥劑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.

官方來源

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