FDA 510(k)

柔性视频胆道-膀胱-尿道镜系统

K号: K211686 · 2022-02-22

申请人Shanghai SeeGen Photoelectric Technology Co., Ltd.

决定日期2022-02-22

产品代码FGB

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决定实质等同

器械摘要

Flexible Video-Choledo-Cysto-Ureteroscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-22 under 510(k) number K211686. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Flexible Video-Choledo-Cysto-Ureteroscope System?

Flexible Video-Choledo-Cysto-Ureteroscope System is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K211686.

When did Flexible Video-Choledo-Cysto-Ureteroscope System receive FDA 510(k) clearance?

Flexible Video-Choledo-Cysto-Ureteroscope System received FDA 510(k) clearance on 2022-02-22, under 510(k) number K211686.

Who is the listed applicant for Flexible Video-Choledo-Cysto-Ureteroscope System?

The FDA 510(k) record lists Shanghai SeeGen Photoelectric Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System?

The FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System is FGB.

列明Shanghai SeeGen Photoelectric 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。

K252457一次性远端端头胶带罩 K243535柔性视频胆道镜（CHV-110J-U）；柔性视频胆道镜（CHV-US120J-U）K241532柔性视频胆道-膀胱-尿道镜系统（PL-2100）K222499一次性内镜阀门组件套件 K222261柔性视频胆道镜系统

相关器械（代码：FGB）

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。

K261447CVAC® 吸引系统Calyxo, Inc.K262488一次性使用视频软性输尿管肾镜（RP-U-C06R9，RP-U-C06R3，RP-U-C06S9，RP-U-C06S3）Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite 数字柔性输尿管镜系统Boston Scientific Corporation 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）Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView 单次使用数字柔性膀胱镜（C38-CS，C38-CRS，C50-C，C50-CR，C50-CB，C50-CBR）MacroLux Medical Technology Co., Ltd.

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