FDA 510(k)

Niti-S 十二指腸舒適支架，Niti-S 大腸舒適支架

K 號：K250663 · 2025-03-31

決定日期2025-03-31

產品代碼MUM

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

Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort 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 2025-03-31 under 510(k) number K250663. The device is classified under product code MUM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent?

Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent is a medical device that received FDA 510(k) clearance on 2025-03-31. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K250663.

When did Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent receive FDA 510(k) clearance?

Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent received FDA 510(k) clearance on 2025-03-31, under 510(k) number K250663.

Who is the listed applicant for Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort 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 Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent?

The FDA product code for Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent is MUM.

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 K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent K223626Niti-S 胆道速通 D 篩管

查看所有 11 項裝置 →

相關器械（代碼：MUM）

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。

K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd.K163468進化十二指腸支架系統 - 開放式，進化結腸支架系統 - 開放式Cook Ireland, Ltd.

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。