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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 / 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: K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261488 (OBSIDIO Conformable Embolic), K262165 (FARADRIVE Steerable Sheath (M004PF21M402)), K262462 (TheraSphere 360 Y-90 Management Platform).

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