LumenaTM输尿管通道鞘
K号: K250585 · 2025-06-27
广告
决定日期2025-06-27
产品代码FED
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
LumenaTM Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Cathegenix (Xiamen) Co., Ltd.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K250585. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LumenaTM Ureteral Access Sheath?
LumenaTM Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Cathegenix (Xiamen) Co., Ltd.. The 510(k) number is K250585.
When did LumenaTM Ureteral Access Sheath receive FDA 510(k) clearance?
LumenaTM Ureteral Access Sheath received FDA 510(k) clearance on 2025-06-27, under 510(k) number K250585.
Who is the listed applicant for LumenaTM Ureteral Access Sheath?
The FDA 510(k) record lists Cathegenix (Xiamen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LumenaTM Ureteral Access Sheath?
The FDA product code for LumenaTM Ureteral Access Sheath is FED.
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。
列明Cathegenix (Xiamen) 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。
相关器械（代码：FED）
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。
K260512一次性输尿管通道鞘Yangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder 内窥镜外管Neptune Medical, Inc.K260410单次使用输尿管通道鞘Zhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex 肾盂输尿管通路鞘套装Boston Scientific CorporationK260965CVAC吸引系统Calyxo, Inc.K260521ClearEVAC输尿管吸引接入鞘（PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250）Zhuhai Pusen Medical Technology Co., Ltd.
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。
广告