Senhance超声波系统
K号: K254192 · 2026-05-12
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决定日期2026-05-12
产品代码NAY
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
Senhance Ultrasonic System is the device name listed in this FDA 510(k) record. The listed applicant is Asensus Surgical. It received FDA 510(k) clearance on 2026-05-12 under 510(k) number K254192. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Senhance Ultrasonic System?
Senhance Ultrasonic System is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is Asensus Surgical. The 510(k) number is K254192.
When did Senhance Ultrasonic System receive FDA 510(k) clearance?
Senhance Ultrasonic System received FDA 510(k) clearance on 2026-05-12, under 510(k) number K254192.
Who is the listed applicant for Senhance Ultrasonic System?
The FDA 510(k) record lists Asensus Surgical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Senhance Ultrasonic System?
The FDA product code for Senhance Ultrasonic System is NAY.
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：NAY）
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。
K261823达芬奇手术系统，型号IS5000Intuitive Surgical, Inc.K261824达芬奇手术系统，型号IS5000Intuitive Surgical, Inc.K260695达芬奇萤火虫成像系统Intuitive SurgicalK253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.K253556达芬奇SP手术系统（SP1098）；达芬奇E-200发生器Intuitive Surgical, Inc.K251739达芬奇手术系统（IS5000）Intuitive Surgical, Inc.
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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