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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 / April 2026 / K251658

510(k) cleared

Endoflux Biliary & Pancreatic Stent Sets

Medi-Globe GmbH · Apr 16, 2026 · K251658

FDA cleared the Endoflux Biliary & Pancreatic Stent Sets from Medi-Globe GmbH on Apr 16, 2026 under K251658, a traditional 510(k). The device falls under product code FGE, Stents, Drains And Dilators For The Biliary Ducts, regulated at 21 CFR 876.5010 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 30, 2025. The decision came 321 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 Medi-Globe GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251658?

K251658 is the FDA 510(k) for Endoflux Biliary & Pancreatic Stent Sets, submitted by Medi-Globe GmbH. FDA's decision date was Apr 16, 2026, under product code FGE (Stents, Drains And Dilators For The Biliary Ducts).

Who makes the Endoflux Biliary & Pancreatic Stent Sets?

Medi-Globe GmbH, based in Achenmuehle, is the applicant of record for K251658.

How long did the K251658 review take?

FDA received the submission on May 30, 2025 and issued its decision on Apr 16, 2026, 321 days later.

← All decisions in April 2026