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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 / June 2026 / K260428

510(k) cleared

RIVOS EUS Access Device (M00553900)

Boston Scientific Corporation · Jun 17, 2026 · K260428

FDA cleared the RIVOS EUS Access Device (M00553900) from Boston Scientific Corporation on Jun 17, 2026 under K260428, a traditional 510(k). The device falls under product code ODG, Endoscopic Ultrasound System, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Feb 10, 2026. The decision came 127 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Boston Scientific Corporation has 8 other decisions in the tracker over the last 12 months: K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261488 (OBSIDIO Conformable Embolic), K262165 (FARADRIVE Steerable Sheath (M004PF21M402)), K262462 (TheraSphere 360 Y-90 Management Platform).

Questions & Answers

What did FDA clear under K260428?

K260428 is the FDA 510(k) for RIVOS EUS Access Device (M00553900), submitted by Boston Scientific Corporation. FDA's decision date was Jun 17, 2026, under product code ODG (Endoscopic Ultrasound System, Gastroenterology-Urology).

Who makes the RIVOS EUS Access Device (M00553900)?

Boston Scientific Corporation, based in Marlboro, MA, is the applicant of record for K260428.

How long did the K260428 review take?

FDA received the submission on Feb 10, 2026 and issued its decision on Jun 17, 2026, 127 days later.

← All decisions in June 2026