SIRIUS 内窥镜系统
K号: K221642 · 2022-12-12
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决定日期2022-12-12
产品代码HET
咨询委员会OB
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器械摘要
SIRIUS Endoscope System 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 2022-12-12 under 510(k) number K221642. 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?
SIRIUS Endoscope System is a medical device that received FDA 510(k) clearance on 2022-12-12. The listed applicant is Precision Robotics (Hong Kong) Limited. The 510(k) number is K221642.
When did SIRIUS Endoscope System receive FDA 510(k) clearance?
SIRIUS Endoscope System received FDA 510(k) clearance on 2022-12-12, under 510(k) number K221642.
Who is the listed applicant for SIRIUS Endoscope System?
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?
The FDA product code for SIRIUS Endoscope System is HET.
相关临床试验
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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。
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。
K250939SIRIUS 内窥镜系统 (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK210116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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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