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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 / August 2026 / K262406

510(k) cleared

EluPro Antibiotic-Eluting BioEnvelope

Boston Scientific · Aug 12, 2026 · K262406

FDA cleared the EluPro Antibiotic-Eluting BioEnvelope from Boston Scientific on Aug 12, 2026 under K262406, a special 510(k). The device falls under product code FTM, Mesh, Surgical, regulated at 21 CFR 878.3300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 15, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Boston Scientific has 8 other decisions in the tracker over the last 12 months: K261488 (OBSIDIO Conformable Embolic), 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 K262406?

K262406 is the FDA 510(k) for EluPro Antibiotic-Eluting BioEnvelope, submitted by Boston Scientific. FDA's decision date was Aug 12, 2026, under product code FTM (Mesh, Surgical).

Who makes the EluPro Antibiotic-Eluting BioEnvelope?

Boston Scientific, based in Saint Paul, MN, is the applicant of record for K262406.

How long did the K262406 review take?

FDA received the submission on Jul 15, 2026 and issued its decision on Aug 12, 2026, 28 days later.

← All decisions in August 2026