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FDA 510(k)

PENTAX醫療內視鏡攝影十二指腸內視鏡（ED34-i10T2s）；PENTAX醫療內視鏡處理器（EPK-i8020c）；PENTAX醫療一次性、无菌遠端蓋子帶提升器（OE-A63）；氣/水供給閥（OF-B194）

K 號：K233942 · 2024-08-01

申請人Pentax of America, Inc.
決定日期2024-08-01
產品代碼FDT
諮詢委員會GU
決定相當於

器材摘要

PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K233942. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )?

PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Pentax of America, Inc.. The 510(k) number is K233942.

When did PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) receive FDA 510(k) clearance?

PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) received FDA 510(k) clearance on 2024-08-01, under 510(k) number K233942.

Who is the listed applicant for PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )?

The FDA product code for PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) is FDT.

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 Pentax of America, 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。

K251256PENTAX醫療內視鏡上消化道內視鏡（EG系列）（EG系列）；PENTAX醫療內視鏡結腸內視鏡（EC系列）（EC系列）K251127PENTAX醫療影片處理器（EPK-i8020c）K242110PENTAX醫療內視鏡視頻結腸鏡（EC38-i20cWL）K241213PENTAX醫療內視鏡上消化道內視鏡（EG27-i20c）；PENTAX醫療內視鏡結腸內視鏡（EC34-i20cL）K240457C2 冷氣球消融系統（C2 冷氣球消融系統）K232860PENTAX醫療影片處理器EPK-i8020c，PENTAX醫療影片支氣管內鏡EB11-J10，PENTAX醫療影片支氣管內鏡EB15-J10，PENTAX醫療影片支氣管內鏡EB19-J10U，PENTAX醫療超聲波影片支氣管內鏡EB19-J10U

查看所有 39 項裝置 →

相關器械（代碼：FDT）

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。

K251861富士通內視鏡型號 ED-S100TP；富士通內視鏡型號 ED-S100XP；富士通處理器型號 VS-1000Fujifilm CorporationK253646單次使用遠端蓋 MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III 十二指腸內視鏡 奧林巴斯 TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III 十二指腸內視鏡 奧林巴斯 TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/SK220587Evis Exera III 十二指腸內視鏡 奧林巴斯 TJF-Q190VOlympus Medical Systems Corp.

官方來源

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