LumiRex 肾盂镜
K号: K243532 · 2025-04-28
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决定日期2025-04-28
产品代码FGB
咨询委员会GU
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决定实质等同
器械摘要
LumiRex Ureteroscope is the device name listed in this FDA 510(k) record. The listed applicant is Contra Healthcare Solutions, LLC. It received FDA 510(k) clearance on 2025-04-28 under 510(k) number K243532. 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 LumiRex Ureteroscope?
LumiRex Ureteroscope is a medical device that received FDA 510(k) clearance on 2025-04-28. The listed applicant is Contra Healthcare Solutions, LLC. The 510(k) number is K243532.
When did LumiRex Ureteroscope receive FDA 510(k) clearance?
LumiRex Ureteroscope received FDA 510(k) clearance on 2025-04-28, under 510(k) number K243532.
Who is the listed applicant for LumiRex Ureteroscope?
The FDA 510(k) record lists Contra Healthcare Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LumiRex Ureteroscope?
The FDA product code for LumiRex Ureteroscope is FGB.
相关临床试验
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列明Contra Healthcare Solutions, LLC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：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。
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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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