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FDA 510(k)

VersaOne 光学套管 15mm，VersaOne 无刀套管 15mm

K号: K160230 · 2016-03-01

申请人Covidien
决定日期2016-03-01
产品代码GCJ
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-03-01 under 510(k) number K160230. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm?

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm is a medical device that received FDA 510(k) clearance on 2016-03-01. The listed applicant is Covidien. The 510(k) number is K160230.

When did VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm receive FDA 510(k) clearance?

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm received FDA 510(k) clearance on 2016-03-01, under 510(k) number K160230.

Who is the listed applicant for VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm?

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

What is the FDA product code for VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm?

The FDA product code for VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm is GCJ.

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官方来源

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