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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 / March 2026 / K251273

510(k) cleared

Asurys Fluid Management System

Boston Scientific Corporation · Mar 27, 2026 · K251273

FDA cleared the Asurys Fluid Management System from Boston Scientific Corporation on Mar 27, 2026 under K251273, a traditional 510(k). The device falls under product code HIG, Insufflator, Hysteroscopic, regulated at 21 CFR 884.1700 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Apr 24, 2025. The decision came 337 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K251273?

K251273 is the FDA 510(k) for Asurys Fluid Management System, submitted by Boston Scientific Corporation. FDA's decision date was Mar 27, 2026, under product code HIG (Insufflator, Hysteroscopic).

Who makes the Asurys Fluid Management System?

Boston Scientific Corporation, based in Marborough, MA, is the applicant of record for K251273.

How long did the K251273 review take?

FDA received the submission on Apr 24, 2025 and issued its decision on Mar 27, 2026, 337 days later.

← All decisions in March 2026