SurgiCube
K 號：K163455 · 2017-09-28
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器材摘要
SurgiCube is the device name listed in this FDA 510(k) record. The listed applicant is Surgicube International B.V.. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K163455. The device is classified under product code ORC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SurgiCube?
SurgiCube is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Surgicube International B.V.. The 510(k) number is K163455.
When did SurgiCube receive FDA 510(k) clearance?
SurgiCube received FDA 510(k) clearance on 2017-09-28, under 510(k) number K163455.
Who is the listed applicant for SurgiCube?
The FDA 510(k) record lists Surgicube International B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SurgiCube?
The FDA product code for SurgiCube is ORC.
相關臨床試驗
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相關器械（代碼：ORC）
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。
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。
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