Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K252400
Device Name Endomina EZFuse system
Applicant
Endo Tools Therapeutics S.A.
Rue Clément Ader, 10
Gosselies,  BE 6041
Applicant Contact Marine Rouyer
Correspondent
Endo Tools Therapeutics S.A.
Rue Clément Ader, 10
Gosselies,  BE 6041
Correspondent Contact Marine Rouyer
Regulation Number876.1500
Classification Product Code
OCW  
Date Received07/31/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-