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FDA 510(k)

柔性视频输尿管肾镜SSU系统

K号: K212458 · 2022-01-20

申请人Karl Storz Endoscopy America
决定日期2022-01-20
产品代码FGB
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

Flexible Video-Uretero-Renoscope SSU System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K212458. 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-Uretero-Renoscope SSU System?

Flexible Video-Uretero-Renoscope SSU System is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Karl Storz Endoscopy America. The 510(k) number is K212458.

When did Flexible Video-Uretero-Renoscope SSU System receive FDA 510(k) clearance?

Flexible Video-Uretero-Renoscope SSU System received FDA 510(k) clearance on 2022-01-20, under 510(k) number K212458.

Who is the listed applicant for Flexible Video-Uretero-Renoscope SSU System?

The FDA 510(k) record lists Karl Storz Endoscopy America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Video-Uretero-Renoscope SSU System?

The FDA product code for Flexible Video-Uretero-Renoscope SSU System is FGB.

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Karl Storz Endoscopy America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。

K212656柔性气管插管视频内窥镜 - 无菌（FIVE-S）K212695KARL STORZ ICG成像系统K201001Modulith SLX-F2K201526TIPCAM1 Rubina 视频内窥镜系统

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 CorporationK262552一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.

官方来源

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