FDA 510(k)

WallFlex 食道支架系統；Agile 食道穿過導管（OTW）支架系統

K 號：K261978 · 2026-07-10

決定日期2026-07-10

產品代碼ESW

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

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K261978. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System?

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Boston Scientific Corporation. The 510(k) number is K261978.

When did WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System receive FDA 510(k) clearance?

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System received FDA 510(k) clearance on 2026-07-10, under 510(k) number K261978.

Who is the listed applicant for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System?

The FDA product code for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System is ESW.

其他以 Boston Scientific Corporation 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。

K262151SpaceOAR Flex™ 系統 K261153LithoVue Elite數位柔軟輸尿管鏡系統 K261915導航™ Flex 腎管進入鞘組合 K262165FARADRIVE™操縱式鞘 (M004PF21M402)K262462TheraSphere 360™ Y-90 管理平台 K261488OBSIDIO 可調適性栓塊

查看所有 167 項裝置 →

相關器械（代碼：ESW）

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。

K253327HANAROSTENT 食道上段 (CCC)M.I.Tech Co., Ltd.K243619Niti-S 食管支架；食管TTS支架Taewoong Medical Co., Ltd.K251265耐久全覆蓋食道支架系統Merit Medical Systems, Inc.K233939超柔靜食道內氣管支架系統；壁柔靜食道支架系統Boston Scientific K233837Agile 食管支架系統Boston Scientific Corporation K240522食道TTS支架Taewoong Medical

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。