Pathfinder 内窥镜外管带球囊装置
K号: K230801 · 2023-07-28
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决定日期2023-07-28
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
Pathfinder Endoscope Overtube with Balloon Device is the device name listed in this FDA 510(k) record. The listed applicant is Neptune Medical, Inc.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K230801. 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 Pathfinder Endoscope Overtube with Balloon Device?
Pathfinder Endoscope Overtube with Balloon Device is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Neptune Medical, Inc.. The 510(k) number is K230801.
When did Pathfinder Endoscope Overtube with Balloon Device receive FDA 510(k) clearance?
Pathfinder Endoscope Overtube with Balloon Device received FDA 510(k) clearance on 2023-07-28, under 510(k) number K230801.
Who is the listed applicant for Pathfinder Endoscope Overtube with Balloon Device?
FDA 510(k)记录中列出了Neptune Medical, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Pathfinder Endoscope Overtube with Balloon Device?
The FDA product code for Pathfinder Endoscope Overtube with Balloon Device 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Neptune Medical, Inc.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。
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