Endo Tools Therapeutics S.A. - FDA 510(k) Cleared Devices

Endo Tools Therapeutics S.A., is dedicated to developing innovative endoscopic devices for gastric and urological conditions. Based in Gosselies, Belgium, the company focuses on minimally invasive therapeutic interventions using natural orifice access. The endomina® system represents their core technology, enabling endoscopic suturing and tissue approximation procedures.

The company has received 2 FDA 510(k) clearances from 2 total submissions since 2021. All submissions focus on Gastroenterology & Urology devices. The latest clearance in 2026 demonstrates continued regulatory activity and product innovation in this specialty.

Endo Tools Therapeutics' devices are designed to provide physicians with enhanced maneuverability and improved patient outcomes through incisionless surgical techniques. The company's technology has been used in clinical practice across Europe and is now available in the United States market following FDA clearance.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the 510(k) database.