EndoDrill® 型號 X
K 號：K212423 · 2023-03-29
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器材摘要
EndoDrill® Model X is the device name listed in this FDA 510(k) record. The listed applicant is Bibbinstruments AB. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K212423. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EndoDrill® Model X?
EndoDrill® Model X is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Bibbinstruments AB. The 510(k) number is K212423.
When did EndoDrill® Model X receive FDA 510(k) clearance?
EndoDrill® Model X received FDA 510(k) clearance on 2023-03-29, under 510(k) number K212423.
Who is the listed applicant for EndoDrill® Model X?
The FDA 510(k) record lists Bibbinstruments AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EndoDrill® Model X?
The FDA product code for EndoDrill® Model X is FCG.
相關臨床試驗
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相關器械（代碼：FCG）
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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