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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 / 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: 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 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