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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 / January 2026 / K253730

510(k) cleared

RoVo Mechanical Thrombectomy System

Verge Medical, Inc. · Jan 21, 2026 · K253730

FDA cleared the RoVo Mechanical Thrombectomy System from Verge Medical, Inc. on Jan 21, 2026 under K253730, a special 510(k). The device falls under product code QEW, Peripheral Mechanical Thrombectomy With Aspiration, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 24, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

Verge Medical, Inc. has one other decision in the tracker over the last 12 months: K254022 (FLASH Flex Aorto-Ostial Angioplasty System).

Questions & Answers

What did FDA clear under K253730?

K253730 is the FDA 510(k) for RoVo Mechanical Thrombectomy System, submitted by Verge Medical, Inc.. FDA's decision date was Jan 21, 2026, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the RoVo Mechanical Thrombectomy System?

Verge Medical, Inc., based in Campbell, CA, is the applicant of record for K253730.

How long did the K253730 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Jan 21, 2026, 58 days later.

← All decisions in January 2026

Sources