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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 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.

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. 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.

Other records listing Endogastric Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesK172811EsophyX Z, EsophyX2 HDK171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories

Related Devices (Code: ODE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233240GERDX-SystemG-Surg GmbHK240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.

Official Source

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

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