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Data / Medical devices / Belgium / Endo Tools Therapeutics S.A

Endo Tools Therapeutics S.A: FDA-registered device maker in Anderlecht Brussels-Capital Region, Belgium, 2 510(k) clearances

Endo Tools Therapeutics S.A is registered with the FDA (registration 3021721805) in Anderlecht Brussels-Capital Region, Belgium. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 13, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3021721805
Address
Allee de la Recherche, 12, Anderlecht Brussels-Capital Region, Belgium, 1070
Owner or operator
Endo Tools Therapeutics S.A (10084358)
Roles
Manufacturer
First device listed
February 14, 2022
Registered through
2026
Brand names listed
endomina EZFuse system, endomina(r) system

Devices it lists

DeviceProduct codeClassRoleSource
Endoscopic Tissue Approximation DeviceOCW2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 13, 2026K252400Endomina EZFuse systemOCWSubstantially EquivalentEndo Tools Therapeutics S.A.accessdata.fda.gov
December 7, 2021K211309endomina systemOCWSubstantially EquivalentEndo Tools Therapeutics S.A.accessdata.fda.gov

Compare with other makers

Updated February 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.