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FDA 510(k)

da Vinci Xi Surgical System

K号: K153276 · 2016-08-07

申请人Intuitive Surgical, Inc.
决定日期2016-08-07
产品代码NAY
咨询委员会GU
决定Substantially Equivalent

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, Inc.. It received FDA 510(k) clearance on 2016-08-07 under 510(k) number K153276. 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 2016-08-07. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K153276.

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

da Vinci Xi Surgical System received FDA 510(k) clearance on 2016-08-07, under 510(k) number K153276.

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

The FDA 510(k) record lists Intuitive Surgical, Inc. 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.

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。

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

列明Intuitive Surgical, 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。

K261823da Vinci Surgical System, Model IS5000K253702Intuitive Endoluminal Gastrointestinal System (IG1000)K261824da Vinci Surgical System, Model IS5000K261249Universal Seal (5-12 mm)K253986da Vinci Force Feedback InstrumentsK253978Universal Seal (5-12 mm)

查看所有 111 个设备 →

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。

K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.K260695da Vinci Firefly Imaging SystemIntuitive SurgicalK254192Senhance Ultrasonic SystemAsensus SurgicalK253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.

官方来源

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