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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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: K262151 (SpaceOAR Flex System), K262460 (Rezum System), K261153 (LithoVue Elite Digital Flexible Ureteroscope System), K253692 (AVVIGO+ Multi-Modality Guidance 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