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EsophyX Z Fastener Delivery Device

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

510(k) K143645 Product code ODE

Overview

The EsophyX Z Fastener Delivery Device is an endoscopic suture/plication system used for transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy and for narrowing the gastroesophageal junction.

The device is supplied as part of a system that includes SerosaFuse implantable fasteners and accessories. It is used under direct endoscopic visualization with placement over a flexible gastroscope. The device has received FDA 510(k) clearance under k-number K143645 and is classified as a Class II medical device with product code ODE.

Summary written by AI from registry data, 26 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 NumberK143645 Date4 Mar 2015ClearedStatusActive

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 EsophyX Z Fastener Delivery Device used for?

    The EsophyX Z Fastener Delivery Device is an endoscopic suture/plication system used for transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is specifically indicated for treating symptomatic chronic GERD in patients who require and respond to pharmacological therapy, and for narrowing the gastroesophageal junction.

  • How is the EsophyX Z Fastener Delivery Device supplied?

    The device is supplied as part of a system that includes SerosaFuse implantable fasteners and necessary accessories. It is designed to be used under direct endoscopic visualization with placement over a flexible gastroscope, ensuring precise tissue approximation during procedures.

  • What is the regulatory status of the EsophyX Z Fastener Delivery Device?

    The EsophyX Z Fastener Delivery Device has received FDA 510(k) clearance under k-number K143645. It is classified as a Class II medical device with product code ODE. The clearance was determined through the traditional review process and deemed substantially equivalent to predicate devices.

  • Is the EsophyX Z Fastener Delivery Device reusable or single-use?

    The device information does not specify whether the EsophyX Z Fastener Delivery Device is designed for single-use or multiple uses. However, it is supplied with implantable SerosaFuse fasteners, which are typically single-use components. The specific reuse policy would be determined by the manufacturer's instructions for use.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K143645 24 fields · synced 6 Oct 2026