FDA 510(k)

GYNECARE TVT 可重用導入器，GYNECARE TVT 可重用硬質導管導向器，GYNECARE TVT EXACT 控尿系統 Trocar

K 號：K173019 · 2018-07-06

決定日期2018-07-06

產品代碼PWJ

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2018-07-06 under 510(k) number K173019. The device is classified under product code PWJ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar?

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is ETHICON, Inc.. The 510(k) number is K173019.

When did GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar receive FDA 510(k) clearance?

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar received FDA 510(k) clearance on 2018-07-06, under 510(k) number K173019.

Who is the listed applicant for GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar?

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

What is the FDA product code for GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar?

The FDA product code for GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar is PWJ.

其他以 ETHICON, Inc. 為申請人之記錄

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相關器械（代碼：PWJ）

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。

K181151GYNECARE TVT Abbrevo 經濟尿失禁系統；GYNECARE TVT 遮斷器尿失禁系統ETHICON, Inc.K173162GYNECARE TVT 腹部導引器和連接器，GYNECARE TVT 可重用導入器，GYNECARE TVT 可重用硬質導管導引器ETHICON, Inc.K172614卡德拉醫療經陰道螺旋導入器，左側；卡德拉醫療經陰道螺旋導入器，右側；卡德拉醫療經陰道大型螺旋導入器，左側；卡德拉醫療經陰道大型螺旋導入器，右側；卡德拉醫療經陰道內外螺旋導入器，左側Caldera Medical, Inc.K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery DeviceBoston Scientific Corporation

官方來源

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