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FDA 510(k)

SIRIUS 内窥镜系统 (PR-SI-1230)

K号: K250939 · 2025-08-29

申请人Precision Robotics (Hong Kong) Limited
决定日期2025-08-29
产品代码HET
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决定实质等同

器械摘要

SIRIUS Endoscope System (PR-SI-1230) is the device name listed in this FDA 510(k) record. The listed applicant is Precision Robotics (Hong Kong) Limited. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K250939. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SIRIUS Endoscope System (PR-SI-1230)?

SIRIUS Endoscope System (PR-SI-1230) is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Precision Robotics (Hong Kong) Limited. The 510(k) number is K250939.

When did SIRIUS Endoscope System (PR-SI-1230) receive FDA 510(k) clearance?

SIRIUS Endoscope System (PR-SI-1230) received FDA 510(k) clearance on 2025-08-29, under 510(k) number K250939.

Who is the listed applicant for SIRIUS Endoscope System (PR-SI-1230)?

The FDA 510(k) record lists Precision Robotics (Hong Kong) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIRIUS Endoscope System (PR-SI-1230)?

The FDA product code for SIRIUS Endoscope System (PR-SI-1230) is HET.

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Precision Robotics (Hong Kong) Limited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。

K221642SIRIUS 内窥镜系统

相关器械（代码：HET）

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。

K243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS 内窥镜系统Precision Robotics (Hong Kong) LimitedK210116视频内镜系统，3D视频内镜系统Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope系统270surgical , Ltd.K201617TipVision 视频内窥镜系统（TipVision 视频内窥镜 0°/30°；EleVision HD 2 摄像机控制单元（CCU））Schoelly Fiberoptic GmbH

官方来源

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