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FDA 510(k)

胆管镜可视化系统（一次性视频胆管镜：SCV-P-01G，SCV-P-02G；全高清可视化内镜图像处理器：HDVS-S300A，HDVS-S300B，HDVS-S300C，HDVS-S300D）

K号: K251338 · 2026-01-20

申请人Scivita Medical Technology Co., Ltd.
决定日期2026-01-20
产品代码FBN
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

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.

常见问题

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)记录将斯奇维塔医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Scivita Medical Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262552一次性使用柔性输尿管镜（一次性使用柔性输尿管镜：SUV-5C-B）K243708泌尿外科视频内镜系统（一次性使用柔性输尿管镜：SUV-1A-B，SUV-1A-P，SUV-2A-B，SUV-2A-P，SUV-2B-B，SUB-2B-P，SUV-2C-B，SUV-2C-P；一次性使用柔性膀胱镜：SUV-1D-B，SUV-1D-P；内镜图像处理器：HDVS-S100A，HDVS-S100D。）K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))K240289全高清内镜图像处理器（HDVS-S200A，HDVS-S200B，HDVS-S200C，HDVS-S200D）K240192一次性使用提取篮K231521Broncho Videoscope System

查看所有 13 个设备 →

相关器械（代码：FBN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254153一次性视频内镜；PB数字控制器Mirco-Tech (Nanjing) Co., Ltd.K253139一次性远端帽Mirco-Tech (Nanjing) Co., Ltd.K251170Tangent 单次使用数字系统：Tangent 单次使用数字导管和 Tangent 数字控制器Tangent Endoscopy, LLCK243535柔性视频胆道镜（CHV-110J-U）；柔性视频胆道镜（CHV-US120J-U）Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444胆胰管内窥镜系统Shenzhen HugeMed Medical Technical Development Co., Ltd.K233752Dragonfly® 胰胆镜；Dragonfly® 数字控制器；Dragonfly® 工具通道盖CenterPoint Systems, LLC

官方来源

在 FDA 数据库中查看 →

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