FDA 510(k)

Niti-S 胆道速通 D 篩管

K 號：K223626 · 2023-05-26

決定日期2023-05-26

產品代碼FGE

諮詢委員會GU

決定Unknown

器材摘要

Niti-S Biliary Speed D 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 2023-05-26 under 510(k) number K223626. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the Niti-S Biliary Speed D Stent?

Niti-S Biliary Speed D Stent is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K223626.

When did Niti-S Biliary Speed D Stent receive FDA 510(k) clearance?

Niti-S Biliary Speed D Stent received FDA 510(k) clearance on 2023-05-26, under 510(k) number K223626.

Who is the listed applicant for Niti-S Biliary Speed D 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 Biliary Speed D Stent?

The FDA product code for Niti-S Biliary Speed D Stent is FGE.

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

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相關器械（代碼：FGE）

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。

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