Versius手术系统（Versius Plus）
K号: K252111 · 2025-12-16
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决定日期2025-12-16
产品代码SCV
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Versius Surgical System (Versius Plus) is the device name listed in this FDA 510(k) record. The listed applicant is Cmr Surgical Limited. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K252111. The device is classified under product code SCV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Versius Surgical System (Versius Plus)?
Versius Surgical System (Versius Plus) is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Cmr Surgical Limited. The 510(k) number is K252111.
When did Versius Surgical System (Versius Plus) receive FDA 510(k) clearance?
Versius Surgical System (Versius Plus) received FDA 510(k) clearance on 2025-12-16, under 510(k) number K252111.
Who is the listed applicant for Versius Surgical System (Versius Plus)?
The FDA 510(k) record lists Cmr Surgical Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Versius Surgical System (Versius Plus)?
The FDA product code for Versius Surgical System (Versius Plus) is SCV.
相关临床试验
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相关器械（代码：SCV）
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。
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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