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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 / 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: 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 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