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Endomina EZFuse System

by Endo Tools Therapeutics S.A Belgium 510(k)

510(k) K252400 Product code OCW

Overview

The Endomina EZFuse System is an Endoscopic Tissue Approximation Device. It consists of a triangulation platform and an instrument designed for tissue piercing and approximation. The system features a bendable channel that moves independently from the endoscope, offering a complementary axis of work.

The Endomina EZFuse System is supplied with a single-movement suturing mechanism. It is intended for use in Gastroenterology and Urology. The device has received FDA 510(k) clearance and is classified as a class 2 device with regulation number 876.1500.

Summary written by AI from registry data, 6 Oct 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 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252400 Date13 Feb 2026ClearedStatusActive

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
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  • Expiring
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United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
OCW
FDA applicant
Endo Tools Therapeutics S.A.
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Endo Tools Therapeutics S.A

Questions

  • What is the Endomina EZFuse System used for?

    The Endomina EZFuse System is used for endoscopic tissue approximation in gastroenterology and urology procedures.

  • Is the Endomina EZFuse System supplied with a suturing mechanism?

    Yes, the Endomina EZFuse System is supplied with a single-movement suturing mechanism.

  • What is the regulatory classification of the Endomina EZFuse System?

    The Endomina EZFuse System is classified as a class 2 device with regulation number 876.1500.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K252400 24 fields · synced 22 Oct 2026