微型PCNL系统
K号: K200770 · 2021-07-30
广告
决定日期2021-07-30
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
Mini PCNL-System is the device name listed in this FDA 510(k) record. The listed applicant is Trokamed GmbH. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K200770. 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 Mini PCNL-System?
Mini PCNL-System is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Trokamed GmbH. The 510(k) number is K200770.
When did Mini PCNL-System receive FDA 510(k) clearance?
Mini PCNL-System received FDA 510(k) clearance on 2021-07-30, under 510(k) number K200770.
Who is the listed applicant for Mini PCNL-System?
The FDA 510(k) record lists Trokamed GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mini PCNL-System?
The FDA product code for Mini PCNL-System 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。
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