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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 / K261488

510(k) cleared

OBSIDIO Conformable Embolic

Boston Scientific Corporation · Jul 24, 2026 · K261488

FDA cleared the OBSIDIO Conformable Embolic from Boston Scientific Corporation on Jul 24, 2026 under K261488, a traditional 510(k). The device falls under product code KRD, Device, Vascular, For Promoting Embolization, regulated at 21 CFR 870.3300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 6, 2026. The decision came 79 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), K262165 (FARADRIVE Steerable Sheath (M004PF21M402)), K262462 (TheraSphere 360 Y-90 Management Platform), K261978 (WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System).

Questions & Answers

What did FDA clear under K261488?

K261488 is the FDA 510(k) for OBSIDIO Conformable Embolic, submitted by Boston Scientific Corporation. FDA's decision date was Jul 24, 2026, under product code KRD (Device, Vascular, For Promoting Embolization).

Who makes the OBSIDIO Conformable Embolic?

Boston Scientific Corporation, based in Maple Grove, MN, is the applicant of record for K261488.

How long did the K261488 review take?

FDA received the submission on May 6, 2026 and issued its decision on Jul 24, 2026, 79 days later.

← All decisions in July 2026