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FDA 510(k)

KARL STORZ Flexible Video-Neuro-Endoscope System

K号: K161112 · 2016-09-17

决定日期2016-09-17
产品代码GWG
咨询委员会NE
决定Substantially Equivalent

器械摘要

KARL STORZ Flexible Video-Neuro-Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2016-09-17 under 510(k) number K161112. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KARL STORZ Flexible Video-Neuro-Endoscope System?

KARL STORZ Flexible Video-Neuro-Endoscope System is a medical device that received FDA 510(k) clearance on 2016-09-17. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K161112.

When did KARL STORZ Flexible Video-Neuro-Endoscope System receive FDA 510(k) clearance?

KARL STORZ Flexible Video-Neuro-Endoscope System received FDA 510(k) clearance on 2016-09-17, under 510(k) number K161112.

Who is the listed applicant for KARL STORZ Flexible Video-Neuro-Endoscope System?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ Flexible Video-Neuro-Endoscope System?

The FDA product code for KARL STORZ Flexible Video-Neuro-Endoscope System is GWG.

相关临床试验

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列明KARL STORZ Endoscopy-America, Inc.为申报人的其他记录

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相关器械(代码:GWG)

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。

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