CleverLock 導絲鎖定裝置與活檢帽
K 號：K190164 · 2019-04-04
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器材摘要
CleverLock Guidewire Locking Device and Biopsy Cap is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K190164. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CleverLock Guidewire Locking Device and Biopsy Cap?
CleverLock Guidewire Locking Device and Biopsy Cap is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K190164.
When did CleverLock Guidewire Locking Device and Biopsy Cap receive FDA 510(k) clearance?
CleverLock Guidewire Locking Device and Biopsy Cap received FDA 510(k) clearance on 2019-04-04, under 510(k) number K190164.
Who is the listed applicant for CleverLock Guidewire Locking Device and Biopsy Cap?
FDA 510(k) 記錄將Olympus Surgical Technologies America列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for CleverLock Guidewire Locking Device and Biopsy Cap?
The FDA product code for CleverLock Guidewire Locking Device and Biopsy Cap is ODC.
相關臨床試驗
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其他以 Olympus Surgical Technologies America 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。
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相關器械（代碼：ODC）
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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