FDA 510(k)

单次使用吸引式输尿管镜（PU400A，PU411A），单次使用柔性视频输尿管镜（PU3033H，PU3033AH）

K号: K233778 · 2024-07-16

申请人Zhuhai Pusen Medical Technology Co., Ltd.

决定日期2024-07-16

产品代码FGB

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决定实质等同

器械摘要

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-07-16 under 510(k) number K233778. 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 Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)?

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) is a medical device that received FDA 510(k) clearance on 2024-07-16. The listed applicant is Zhuhai Pusen Medical Technology Co., Ltd.. The 510(k) number is K233778.

When did Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) receive FDA 510(k) clearance?

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) received FDA 510(k) clearance on 2024-07-16, under 510(k) number K233778.

Who is the listed applicant for Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)?

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

What is the FDA product code for Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)?

The FDA product code for Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) is FGB.

列明Zhuhai Pusen Medical 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。

K260521ClearEVAC输尿管吸引接入鞘（PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250）K223741Pusen 单次使用柔性视频膀胱镜/胆道镜系统（单次使用柔性视频膀胱镜/胆道镜：PC200-AS，PC200-AR，PC200-S和PC200-R；高清医用视频内镜图像处理器：PV300）K222602Pusen 单次使用柔性视频膀胱镜系统（单次使用柔性视频膀胱镜：PC200-AS，PC200-AR，PC200-S和PC200-R；高清医用视频内镜图像处理器：PV300）K190648Pusen Eview Medical Video Endoscope Image Processor K172098医疗视频内窥镜系统 K171076医疗视频内窥镜系统

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