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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 / K262462

510(k) cleared

TheraSphere 360 Y-90 Management Platform

Boston Scientific Corporation · Jul 24, 2026 · K262462

FDA cleared the TheraSphere 360 Y-90 Management Platform from Boston Scientific Corporation on Jul 24, 2026 under K262462, a special 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 17, 2026. The decision came 7 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)), K261978 (WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System).

Questions & Answers

What did FDA clear under K262462?

K262462 is the FDA 510(k) for TheraSphere 360 Y-90 Management Platform, submitted by Boston Scientific Corporation. FDA's decision date was Jul 24, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the TheraSphere 360 Y-90 Management Platform?

Boston Scientific Corporation, based in Marlboro, MA, is the applicant of record for K262462.

How long did the K262462 review take?

FDA received the submission on Jul 17, 2026 and issued its decision on Jul 24, 2026, 7 days later.

← All decisions in July 2026