优康系统，优康操作器
K号: K163214 · 2017-02-07
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决定日期2017-02-07
产品代码LKF
咨询委员会OB
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决定实质等同
器械摘要
Unicare System, Unicare Manipulator is the device name listed in this FDA 510(k) record. The listed applicant is Clearpath Surgical, Inc.. It received FDA 510(k) clearance on 2017-02-07 under 510(k) number K163214. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Unicare System, Unicare Manipulator?
Unicare System, Unicare Manipulator is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Clearpath Surgical, Inc.. The 510(k) number is K163214.
When did Unicare System, Unicare Manipulator receive FDA 510(k) clearance?
Unicare System, Unicare Manipulator received FDA 510(k) clearance on 2017-02-07, under 510(k) number K163214.
Who is the listed applicant for Unicare System, Unicare Manipulator?
The FDA 510(k) record lists Clearpath Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Unicare System, Unicare Manipulator?
The FDA product code for Unicare System, Unicare Manipulator is LKF.
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：LKF）
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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