FDA 510(k)

TSolution One 带ACG+ 手术系统

K号: K153647 · 2016-02-16

决定日期2016-02-16

产品代码OLO

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决定实质等同

器械摘要

TSolution One w/ACG+ Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is THINK Surgical, Inc.. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K153647. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TSolution One w/ACG+ Surgical System?

TSolution One w/ACG+ Surgical System is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is THINK Surgical, Inc.. The 510(k) number is K153647.

When did TSolution One w/ACG+ Surgical System receive FDA 510(k) clearance?

TSolution One w/ACG+ Surgical System received FDA 510(k) clearance on 2016-02-16, under 510(k) number K153647.

Who is the listed applicant for TSolution One w/ACG+ Surgical System?

FDA 510(k)记录中列出了THINK Surgical, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for TSolution One w/ACG+ Surgical System?

The FDA product code for TSolution One w/ACG+ Surgical System is OLO.

列明THINK Surgical, Inc.为申报人的其他记录

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