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 a medical device manufactured by Endogastric Solutions, Inc.. It received FDA 510(k) clearance on 2017-10-19 under approval 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. It is manufactured by Endogastric Solutions, Inc.. The 510(k) number is K172811.
When was EsophyX Z, EsophyX2 HD approved by the FDA?
EsophyX Z, EsophyX2 HD received FDA 510(k) clearance on 2017-10-19, under approval number K172811.
What company makes EsophyX Z, EsophyX2 HD?
EsophyX Z, EsophyX2 HD is manufactured by Endogastric Solutions, Inc..
What is the FDA product code for EsophyX Z, EsophyX2 HD?
The FDA product code for EsophyX Z, EsophyX2 HD is ODE.
Other Devices by Endogastric Solutions, Inc.
Related Devices (Code: ODE)
K160960EsophyX® 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.
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.