WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / December 2025 / K251469

510(k) cleared

Endura Ureteral Stent and Stent Set

Cathegenix (Xiamen) Co., Ltd. · Dec 19, 2025 · K251469

FDA cleared the Endura Ureteral Stent and Stent Set from Cathegenix (Xiamen) Co., Ltd. on Dec 19, 2025 under K251469, a traditional 510(k). The device falls under product code FAD, Stent, Ureteral, regulated at 21 CFR 876.4620 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on May 13, 2025. The decision came 220 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 Cathegenix (Xiamen) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251469?

K251469 is the FDA 510(k) for Endura Ureteral Stent and Stent Set, submitted by Cathegenix (Xiamen) Co., Ltd.. FDA's decision date was Dec 19, 2025, under product code FAD (Stent, Ureteral).

Who makes the Endura Ureteral Stent and Stent Set?

Cathegenix (Xiamen) Co., Ltd., based in Xiamen, is the applicant of record for K251469.

How long did the K251469 review take?

FDA received the submission on May 13, 2025 and issued its decision on Dec 19, 2025, 220 days later.

← All decisions in December 2025