Niti-S 胆道輕巧 M 篩管
K 號：K221071 · 2022-06-09
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器材摘要
Niti-S Biliary Slim M 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 2022-06-09 under 510(k) number K221071. 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 Slim M Stent?
Niti-S Biliary Slim M Stent is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K221071.
When did Niti-S Biliary Slim M Stent receive FDA 510(k) clearance?
Niti-S Biliary Slim M Stent received FDA 510(k) clearance on 2022-06-09, under 510(k) number K221071.
Who is the listed applicant for Niti-S Biliary Slim M 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 Slim M Stent?
The FDA product code for Niti-S Biliary Slim M Stent is FGE.
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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。
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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官方來源
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