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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K252400

510(k) cleared

Endomina EZFuse system

Endo Tools Therapeutics S.A. · Feb 13, 2026 · K252400

FDA cleared the Endomina EZFuse system from Endo Tools Therapeutics S.A. on Feb 13, 2026 under K252400, a traditional 510(k). The device falls under product code OCW, Endoscopic Tissue Approximation Device, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 31, 2025. The decision came 197 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Endo Tools Therapeutics S.A. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252400?

K252400 is the FDA 510(k) for Endomina EZFuse system, submitted by Endo Tools Therapeutics S.A.. FDA's decision date was Feb 13, 2026, under product code OCW (Endoscopic Tissue Approximation Device).

Who makes the Endomina EZFuse system?

Endo Tools Therapeutics S.A., based in Gosselies, is the applicant of record for K252400.

How long did the K252400 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Feb 13, 2026, 197 days later.

← All decisions in February 2026