FDA 510(k)

Niti-S SPAXUS支架

K 號：K252648 · 2026-03-13

決定日期2026-03-13

產品代碼PCU

諮詢委員會GU

決定相當於

器材摘要

Niti-S SPAXUS 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 2026-03-13 under 510(k) number K252648. The device is classified under product code PCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Niti-S SPAXUS Stent?

Niti-S SPAXUS Stent is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K252648.

When did Niti-S SPAXUS Stent receive FDA 510(k) clearance?

Niti-S SPAXUS Stent received FDA 510(k) clearance on 2026-03-13, under 510(k) number K252648.

Who is the listed applicant for Niti-S SPAXUS 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 SPAXUS Stent?

The FDA product code for Niti-S SPAXUS Stent is PCU.

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 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 K223626Niti-S 胆道速通 D 篩管

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相關器械（代碼：PCU）

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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官方來源

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