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FDA 510(k)

EsophyX Z, EsophyX2 HD

K-Number: K172811 · 2017-10-19

ApplicantEndogastric Solutions, Inc.
Decision Date2017-10-19
Product CodeODE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EsophyX Z, EsophyX2 HD 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 2017-10-19 under 510(k) number K172811. 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, EsophyX2 HD?

EsophyX Z, EsophyX2 HD is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Endogastric Solutions, Inc.. The 510(k) number is K172811.

When did EsophyX Z, EsophyX2 HD receive FDA 510(k) clearance?

EsophyX Z, EsophyX2 HD received FDA 510(k) clearance on 2017-10-19, under 510(k) number K172811.

Who is the listed applicant for EsophyX Z, EsophyX2 HD?

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, EsophyX2 HD?

The FDA product code for EsophyX Z, EsophyX2 HD 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 AccessoriesK171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and AccessoriesK160960EsophyX® 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.K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.K160960EsophyX® 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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