Weck自動內視鏡5mm自動內視鏡35cm施用器（AE05ML）
K 號：K230480 · 2023-04-28
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器材摘要
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2023-04-28 under 510(k) number K230480. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)?
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Teleflex Medical. The 510(k) number is K230480.
When did Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) receive FDA 510(k) clearance?
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) received FDA 510(k) clearance on 2023-04-28, under 510(k) number K230480.
Who is the listed applicant for Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)?
FDA 510(k) 記錄將Teleflex Medical列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)?
The FDA product code for Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) is FZP.
相關臨床試驗
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。
其他以 Teleflex Medical 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：FZP）
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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