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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 / July 2026 / K260835

510(k) cleared

ARCHIMEDES Biodegradable Stent (Medium)

Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · Jul 27, 2026 · K260835

FDA cleared the ARCHIMEDES Biodegradable Stent (Medium) from Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) on Jul 27, 2026 under K260835, 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 Mar 13, 2026. The decision came 136 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 Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260835?

K260835 is the FDA 510(k) for ARCHIMEDES Biodegradable Stent (Medium), submitted by Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). FDA's decision date was Jul 27, 2026, under product code FGE (Stents, Drains And Dilators For The Biliary Ducts).

Who makes the ARCHIMEDES Biodegradable Stent (Medium)?

Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.), based in Charlotte, NC, is the applicant of record for K260835.

How long did the K260835 review take?

FDA received the submission on Mar 13, 2026 and issued its decision on Jul 27, 2026, 136 days later.

← All decisions in July 2026