幻影XL隔熱擴張器
K 號：K231691 · 2023-06-29
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器材摘要
Phantom XL Insulated Dilators is the device name listed in this FDA 510(k) record. The listed applicant is TeDan Surgical Innovations, Inc.. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K231691. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Phantom XL Insulated Dilators?
Phantom XL Insulated Dilators is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is TeDan Surgical Innovations, Inc.. The 510(k) number is K231691.
When did Phantom XL Insulated Dilators receive FDA 510(k) clearance?
Phantom XL Insulated Dilators received FDA 510(k) clearance on 2023-06-29, under 510(k) number K231691.
Who is the listed applicant for Phantom XL Insulated Dilators?
The FDA 510(k) record lists TeDan Surgical Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Phantom XL Insulated Dilators?
The FDA product code for Phantom XL Insulated Dilators is GXZ.
相關臨床試驗
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相關器械（代碼：GXZ）
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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