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FDA 510(k)

GYNECARE TVT™ 系統、GYNECARE TVT™ 配腹部導引系統、GYNECARE TVT™ 引導器和導管導引器、GYNECARE TVT EXACT™ 控尿系統和 trocar、GYNECARE TVT™ 塞子系統和傳導器及翼形導引器、GYNECARE TVT ABBREVO™ 控尿系統和傳導器及翼形導引器

K 號：K201686 · 2020-09-17

申請人ETHICON, Inc.
決定日期2020-09-17
產品代碼OTN
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2020-09-17 under 510(k) number K201686. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide?

GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is ETHICON, Inc.. The 510(k) number is K201686.

When did GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide receive FDA 510(k) clearance?

GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide received FDA 510(k) clearance on 2020-09-17, under 510(k) number K201686.

Who is the listed applicant for GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide?

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™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide?

The FDA product code for GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide is OTN.

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相關器械（代碼：OTN）

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。

K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP 超聽骨帶系統Urocure, LLCK222468ArcTO Transobturator Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 系統，Desara 藍色 TV EZ 3.0 系統，Desara TV EZ 2.7 系統，Desara 藍色 TV EZ 2.7 系統Caldera Medical, Inc.K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific CorporationK210087Athena 外科 RMUS 系統Athena Surgical, LLC

官方來源

在 FDA 資料庫中查看 →

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