PrimeSight UltraView系统
K号: K253905 · 2026-04-07
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决定日期2026-04-07
产品代码FAJ
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
PrimeSight UltraView System is the device name listed in this FDA 510(k) record. The listed applicant is Cogentix Medical, Inc.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K253905. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PrimeSight UltraView System?
PrimeSight UltraView System is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Cogentix Medical, Inc.. The 510(k) number is K253905.
When did PrimeSight UltraView System receive FDA 510(k) clearance?
PrimeSight UltraView System received FDA 510(k) clearance on 2026-04-07, under 510(k) number K253905.
Who is the listed applicant for PrimeSight UltraView System?
The FDA 510(k) record lists Cogentix Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PrimeSight UltraView System?
The FDA product code for PrimeSight UltraView System is FAJ.
相关临床试验
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列明Cogentix 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：FAJ）
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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