FDA 510(k)

食道TTS支架

K 號：K211706 · 2021-10-08

決定日期2021-10-08

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

Esophageal TTS Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K211706. 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 Esophageal TTS Stent?

Esophageal TTS Stent is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K211706.

When did Esophageal TTS Stent receive FDA 510(k) clearance?

Esophageal TTS Stent received FDA 510(k) clearance on 2021-10-08, under 510(k) number K211706.

Who is the listed applicant for Esophageal TTS Stent?

The FDA 510(k) record lists Taewoong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Esophageal TTS Stent?

The FDA product code for Esophageal TTS Stent is ESW.

其他以 Taewoong Medical Co., Ltd. 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。

K260962括約肌切除器 K252648Niti-S SPAXUS支架 K251123Niti-S 膽道支架；Niti-S 膽道 Slim M 支架 K243619Niti-S 食管支架；食管TTS支架 K250663Niti-S 十二指腸舒適支架，Niti-S 大腸舒適支架 K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent

查看所有 11 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。

K261978WallFlex 食道支架系統；Agile 食道穿過導管（OTW）支架系統Boston Scientific Corporation K243619Niti-S 食管支架；食管TTS支架Taewoong Medical Co., Ltd.K253327HANAROSTENT 食道上段 (CCC)M.I.Tech 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

官方來源

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