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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 / August 2026 / K260572

510(k) cleared

Marrow Marxman

Medimetrix, LLC · Aug 4, 2026 · K260572

FDA cleared the Marrow Marxman from Medimetrix, LLC on Aug 4, 2026 under K260572, a traditional 510(k). The device falls under product code KNW, Instrument, Biopsy, regulated at 21 CFR 876.1075 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 19, 2026. The decision came 166 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 Medimetrix, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260572?

K260572 is the FDA 510(k) for Marrow Marxman, submitted by Medimetrix, LLC. FDA's decision date was Aug 4, 2026, under product code KNW (Instrument, Biopsy).

Who makes the Marrow Marxman?

Medimetrix, LLC, based in Germantown, TN, is the applicant of record for K260572.

How long did the K260572 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Aug 4, 2026, 166 days later.

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