FDA 510(k)

达芬奇Xi手术系统

K号: K152892 · 2016-04-29

决定日期2016-04-29

产品代码NAY

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决定实质等同

器械摘要

da Vinci Xi Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K152892. 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 da Vinci Xi Surgical System?

da Vinci Xi Surgical System is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Intuitive Surgical. The 510(k) number is K152892.

When did da Vinci Xi Surgical System receive FDA 510(k) clearance?

da Vinci Xi Surgical System received FDA 510(k) clearance on 2016-04-29, under 510(k) number K152892.

Who is the listed applicant for da Vinci Xi Surgical System?

The FDA 510(k) record lists Intuitive Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for da Vinci Xi Surgical System?

The FDA product code for da Vinci Xi Surgical System is NAY.

列明Intuitive Surgical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。

K260695达芬奇萤火虫成像系统 K241635达芬奇E-200电外科发生器 K241621Da Vinci Monopolar and Bipolar Adapters (378896)K240723达芬奇Xi手术系统（IS4000）；达芬奇X手术系统（IS4200）K231212达芬奇E-200电外科发生器 K223039达芬奇E-200电外科发生器

查看所有 14 个设备 →

官方来源

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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。