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FDA 510(k)

肝管內視鏡視覺化系統（一次性視覺肝管內視鏡：SCV-P-01G，SCV-P-02G；全高清內視鏡影像處理器：HDVS-S300A，HDVS-S300B，HDVS-S300C，HDVS-S300D）

K 號：K251338 · 2026-01-20

申請人Scivita Medical Technology Co., Ltd.
決定日期2026-01-20
產品代碼FBN
諮詢委員會GU
決定相當於

器材摘要

Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K251338. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)?

Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K251338.

When did Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) receive FDA 510(k) clearance?

Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) received FDA 510(k) clearance on 2026-01-20, under 510(k) number K251338.

Who is the listed applicant for Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)?

FDA 510(k) 記錄將 Scivita Medical Technology Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)?

The FDA product code for Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) is FBN.

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 Scivita Medical Technology Co., Ltd. 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。

K262552單次使用柔軟輸尿管鏡（單次使用柔軟輸尿管鏡：SUV-5C-B）K243708泌尿內視鏡系統（單次使用柔軟輸尿管鏡：SUV-1A-B、SUV-1A-P、SUV-2A-B、SUV-2A-P、SUV-2B-B、SUB-2B-P、SUV-2C-B、SUV-2C-P；單次使用柔軟膀胱鏡：SUV-1D-B、SUV-1D-P；內視鏡圖像處理器：HDVS-S100A、HDVS-S100D。）K250210bronchovideoscope系統（單次使用支氣管內視鏡（SBV-1A-B、SBV-1A-P、SBV-1B-B、SBV-1B-P、SBV-1C-B、SBV-1C-P）；全高清內視鏡影像處理器（HDVS-S300A、HDVS-S300B、HDVS-S300C、HDVS-S300D）；內視鏡影像處理器（HDVS-S100A、HDVS-S100D））K240289全高清內視鏡影像處理器（HDVS-S200A、HDVS-S200B、HDVS-S200C、HDVS-S200D）K240192單次使用抽提籃K231521bronchovideoscope 系統

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相關器械（代碼：FBN）

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。

K254153單次使用視頻內鏡；PB數位控制器Mirco-Tech (Nanjing) Co., Ltd.K253139一次性遠端帽Mirco-Tech (Nanjing) Co., Ltd.K251170Tangent單次使用數位系統：Tangent單次使用數位心导管及Tangent數位控制器Tangent Endoscopy, LLCK243535靈活式內視鏡總管內視鏡（CHV-110J-U）；靈活式內視鏡總管內視鏡（CHV-US120J-U）Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444肝膽胰管內視鏡系統Shenzhen HugeMed Medical Technical Development Co., Ltd.K233752龍飛™ 胰膽鏡；龍飛™ 電子控制器；龍飛™ 器材通道蓋CenterPoint Systems, LLC

官方來源

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