FirstFit 外科工具組
K 號：K240763 · 2024-12-18
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決定日期2024-12-18
產品代碼EWL
諮詢委員會中文(台灣):
此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：
此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。
公司名稱：[公司名稱]
產品名稱：[產品名稱]
決定相當於
器材摘要
FirstFit Surgical Kit is the device name listed in this FDA 510(k) record. The listed applicant is Freudenberg Medical, LLC. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K240763. The device is classified under product code EWL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FirstFit Surgical Kit?
FirstFit Surgical Kit is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Freudenberg Medical, LLC. The 510(k) number is K240763.
When did FirstFit Surgical Kit receive FDA 510(k) clearance?
FirstFit Surgical Kit received FDA 510(k) clearance on 2024-12-18, under 510(k) number K240763.
Who is the listed applicant for FirstFit Surgical Kit?
The FDA 510(k) record lists Freudenberg Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FirstFit Surgical Kit?
The FDA product code for FirstFit Surgical Kit is EWL.
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 Freudenberg Medical, LLC 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。
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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