FDA 510(k)

EsophyX® Z 设备带 SerosaFuse 固定器和附件

K号: K160960 · 2016-05-01

决定日期2016-05-01

产品代码ODE

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决定实质等同

器械摘要

EsophyX® Z Device with SerosaFuse Fasteners and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Endogastric Solutions, Inc.. It received FDA 510(k) clearance on 2016-05-01 under 510(k) number K160960. The device is classified under product code ODE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EsophyX® Z Device with SerosaFuse Fasteners and Accessories?

EsophyX® Z Device with SerosaFuse Fasteners and Accessories is a medical device that received FDA 510(k) clearance on 2016-05-01. The listed applicant is Endogastric Solutions, Inc.. The 510(k) number is K160960.

When did EsophyX® Z Device with SerosaFuse Fasteners and Accessories receive FDA 510(k) clearance?

EsophyX® Z Device with SerosaFuse Fasteners and Accessories received FDA 510(k) clearance on 2016-05-01, under 510(k) number K160960.

Who is the listed applicant for EsophyX® Z Device with SerosaFuse Fasteners and Accessories?

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

What is the FDA product code for EsophyX® Z Device with SerosaFuse Fasteners and Accessories?

The FDA product code for EsophyX® Z Device with SerosaFuse Fasteners and Accessories is ODE.

列明Endogastric Solutions, 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。

K240879EsophyX Z+ 设备带 SerosaFuse 固定器和附件 K172811EsophyX Z, EsophyX2 HD K171307EsophyX2 HD 设备带 SerosaFuse 固定器和附件，EsophyX Z 设备带 SerosaFuse 固定器和附件

官方来源

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