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EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories

by Endogastric Solutions, Inc. United States(FDA 510(k) applicant) 510(k)

510(k) K171307 Product code ODE

Overview

This device is an Endoscopic Suture/Plication System, as defined by its device type and nomenclature. It is designed for transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract.

It is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. The device is supplied with SerosaFuse fasteners and accessories, and is authorized under FDA 510(k) clearance K171307. It is intended for use in gastroenterology and urology settings.

Summary written by AI from registry data, 23 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171307 Date22 Jun 2017ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k) · synced 6 Oct 2026

510(k) Number
FDA Product Code
ODE
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the EsophyX2 HD Device with SerosaFuse Fasteners and Accessories used for?

    It is designed for transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract, specifically indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy.

  • How is the EsophyX2 HD Device supplied and what does it include?

    The device is supplied with SerosaFuse fasteners and accessories as part of the system, which are necessary for performing endoscopic suturing and plication procedures in the GI tract.

  • Is the EsophyX2 HD Device intended for single-use or reuse?

    Based on its classification as an endoscopic suture/plication system with disposable fasteners and accessories, the device components are intended for single-use to ensure sterility and prevent cross-contamination during gastrointestinal procedures.

  • What regulatory pathway was used for the EsophyX2 HD Device?

    The device received FDA 510(k) clearance under submission K171307, indicating it was found substantially equivalent to a legally marketed predicate device for its intended use in endoscopic tissue approximation and plication.

  • In which medical specialties is the EsophyX2 HD Device intended to be used?

    The device is intended for use in gastroenterology and urology settings, as indicated by its medical specialty description and advisory committee classification for gastrointestinal and urological applications.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K171307 24 fields · synced 6 Oct 2026