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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 / February 2026 / K260119

510(k) cleared

SpaceOAR Vue System (SV-2101)

Boston Scientific Corporation · Feb 10, 2026 · K260119

FDA cleared the SpaceOAR Vue System (SV-2101) from Boston Scientific Corporation on Feb 10, 2026 under K260119, a special 510(k). The device falls under product code OVB, Hydrogel Spacer, regulated at 21 CFR 892.5725 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 14, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

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 K260119?

K260119 is the FDA 510(k) for SpaceOAR Vue System (SV-2101), submitted by Boston Scientific Corporation. FDA's decision date was Feb 10, 2026, under product code OVB (Hydrogel Spacer).

Who makes the SpaceOAR Vue System (SV-2101)?

Boston Scientific Corporation, based in Marborough, MA, is the applicant of record for K260119.

How long did the K260119 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on Feb 10, 2026, 27 days later.

← All decisions in February 2026