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FDA 510(k)

一次性使用数字输尿管肾盂镜（GY-UR9.3）；一次性使用数字输尿管肾盂镜（GY-UR8.4）；一次性使用数字输尿管肾盂镜（GY-UR7.5）；内镜摄像头系统（GY-AIO-121）

K号: K252468 · 2025-12-16

申请人Zhejiang Geyi Medical Instrument Co., Ltd.
决定日期2025-12-16
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

Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Geyi Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K252468. 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 Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)?

Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Zhejiang Geyi Medical Instrument Co., Ltd.. The 510(k) number is K252468.

When did Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) receive FDA 510(k) clearance?

Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) received FDA 510(k) clearance on 2025-12-16, under 510(k) number K252468.

Who is the listed applicant for Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)?

FDA 510(k)记录将浙江科益医疗器械有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)?

The FDA product code for Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) 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Zhejiang Geyi Medical Instrument 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。

K254294一次性使用数字宫腔镜（GYUT-A 12.6- 0，GYUT-A12.6- 12，GYUT-A 12.6- 22，GYUT-A 12.6- 30，GYUT-A 14.4- 0，GYUT-A 14.4- 12，GYUT-A 14.4- 22，GYUT-A 14.4- 30，GYUT-B 15- 0，GYUT-B 15- 12，GYUT-B 15-22，GYUT-B 15- 30）

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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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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