經肛導入器
K 號：K171208 · 2018-02-05
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器材摘要
Trans-anal Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2018-02-05 under 510(k) number K171208. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Trans-anal Introducer?
Trans-anal Introducer is a medical device that received FDA 510(k) clearance on 2018-02-05. The listed applicant is Visionsense, Ltd.. The 510(k) number is K171208.
When did Trans-anal Introducer receive FDA 510(k) clearance?
Trans-anal Introducer received FDA 510(k) clearance on 2018-02-05, under 510(k) number K171208.
Who is the listed applicant for Trans-anal Introducer?
The FDA 510(k) record lists Visionsense, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Trans-anal Introducer?
The FDA product code for Trans-anal Introducer is FED.
相關臨床試驗
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其他以 Visionsense, 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：FED）
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
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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