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FDA 510(k)

EsophyX® Z Device with SerosaFuse Fasteners and Accessories

K-Number: K160960 · 2016-05-01

ApplicantEndogastric Solutions, Inc.
Decision Date2016-05-01
Product CodeODE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Endogastric Solutions, Inc.. The 510(k) number is K160960.

When was EsophyX® Z Device with SerosaFuse Fasteners and Accessories approved by the FDA?

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

What company makes EsophyX® Z Device with SerosaFuse Fasteners and Accessories?

EsophyX® Z Device with SerosaFuse Fasteners and Accessories is manufactured by Endogastric Solutions, Inc..

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.

Other Devices by Endogastric Solutions, Inc.

K172811EsophyX Z, EsophyX2 HD K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories K240879EsophyX Z+ Device with SerosaFuse Fasteners and Accessories

Related Devices (Code: ODE)

K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc. K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. K233240GERDX-SystemG-Surg GmbH K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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