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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 / October 2025 / K253376

510(k) cleared

OBSIDIO Conformable Embolic (M0013972101010)

Boston Scientific Corporation · Oct 30, 2025 · K253376

FDA cleared the OBSIDIO Conformable Embolic (M0013972101010) from Boston Scientific Corporation on Oct 30, 2025 under K253376, a special 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 Sep 30, 2025. The decision came 30 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 K253376?

K253376 is the FDA 510(k) for OBSIDIO Conformable Embolic (M0013972101010), submitted by Boston Scientific Corporation. FDA's decision date was Oct 30, 2025, under product code KRD (Device, Vascular, For Promoting Embolization).

Who makes the OBSIDIO Conformable Embolic (M0013972101010)?

Boston Scientific Corporation, based in Maple Grove, MN, is the applicant of record for K253376.

How long did the K253376 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 30, 2025, 30 days later.

← All decisions in October 2025