OptiVu™ 肩部
K 號：K252170 · 2025-08-08
廣告
器材摘要
OptiVu™ Shoulder is the device name listed in this FDA 510(k) record. The listed applicant is Mr Surgical Solutions, LLC. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K252170. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OptiVu™ Shoulder?
OptiVu™ Shoulder is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Mr Surgical Solutions, LLC. The 510(k) number is K252170.
When did OptiVu™ Shoulder receive FDA 510(k) clearance?
OptiVu™ Shoulder received FDA 510(k) clearance on 2025-08-08, under 510(k) number K252170.
Who is the listed applicant for OptiVu™ Shoulder?
The FDA 510(k) record lists Mr Surgical Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OptiVu™ Shoulder?
The FDA product code for OptiVu™ Shoulder is SBF.
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 Mr Surgical Solutions, 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。
相關器械（代碼：SBF）
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。
廣告