Pathfinder內視鏡外管充氣設備
K 號：K230801 · 2023-07-28
廣告
器材摘要
Pathfinder Endoscope Overtube with Balloon Device is the device name listed in this FDA 510(k) record. The listed applicant is Neptune Medical, Inc.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K230801. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Pathfinder Endoscope Overtube with Balloon Device?
Pathfinder Endoscope Overtube with Balloon Device is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Neptune Medical, Inc.. The 510(k) number is K230801.
When did Pathfinder Endoscope Overtube with Balloon Device receive FDA 510(k) clearance?
Pathfinder Endoscope Overtube with Balloon Device received FDA 510(k) clearance on 2023-07-28, under 510(k) number K230801.
Who is the listed applicant for Pathfinder Endoscope Overtube with Balloon Device?
FDA 510(k) 記錄將 Neptun Medical, Inc. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Pathfinder Endoscope Overtube with Balloon Device?
The FDA product code for Pathfinder Endoscope Overtube with Balloon Device is FED.
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 Neptune Medical, Inc. 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：FED）
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。
K260512一次性輸尿管進入鞘Yangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder內視鏡外管Neptune Medical, Inc.K260410單次使用輸尿管進入鞘Zhejiang Chuangxiang Medical Technology Co., Ltd.K261915導航™ Flex 腎管進入鞘組合Boston Scientific CorporationK260965CVAC 吸引系統Calyxo, Inc.K260521ClearEVAC 腎管吸引進入鞘 (PUS-100-1040, PUS-100-1050, PUS-100-1240, PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.
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