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FDA 510(k)

Defendo Pentax 單次使用組織切片閥，Defendo Pentax 單次使用空氣/水閥，Defendo Pentax 單次使用吸引閥，Endogator Pentax 單次使用連接器

K 號：K232004 · 2024-03-06

申請人Medivators (A Subsidiary of Steris Corporation)
決定日期2024-03-06
產品代碼ODC
諮詢委員會GU
決定相當於

器材摘要

Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector is the device name listed in this FDA 510(k) record. The listed applicant is Medivators (A Subsidiary of Steris Corporation). It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K232004. 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 Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector?

Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Medivators (A Subsidiary of Steris Corporation). The 510(k) number is K232004.

When did Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector receive FDA 510(k) clearance?

Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector received FDA 510(k) clearance on 2024-03-06, under 510(k) number K232004.

Who is the listed applicant for Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector?

The FDA 510(k) record lists Medivators (A Subsidiary of Steris Corporation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector?

The FDA product code for Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector is ODC.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Medivators (A Subsidiary of Steris Corporation) 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。

K232067Defendo富士通500/600單次使用空氣/水閥，Defendo富士通500/600單次使用吸引閥，Defendo富士通500/600單次使用針吸閥，Endogator富士通500/600單次使用連接器K232329Defendo富士通700單次使用組織切片閥；Defendo富士通700單次使用空氣/水閥；Defendo富士通700單次使用吸引閥；ENDOGATOR富士通700單次使用連接器；Defendo富士通700單次使用清潔轉接器

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。

K252933DYNE PORTDyne Medical Group, Inc.K250145組織切片端口轉接器Endosound, Inc.K252910Orca 空氣/水及吸引閥Boston ScientificK250949吸引閥 (MAJ-1443)；空氣/水閥 (MAJ-1444)Olympus Medical Systems CorporationK250732一次性內視鏡閥門組Yangzhou Fartley Medical Instrument Technology Co., Ltd.K241842路氏分離 MAJ-2092Olympus Medical Systems Corporation

官方來源

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