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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 / July 2026 / K261448

510(k) cleared

neXus Ultrasonic Surgical Aspirator System

Misonix, LLC · Jul 30, 2026 · K261448

FDA cleared the neXus Ultrasonic Surgical Aspirator System from Misonix, LLC on Jul 30, 2026 under K261448, a traditional 510(k). The device falls under product code LFL, Instrument, Ultrasonic Surgical as a Class U device. The review panel was Unknown.

FDA logged the submission as received on May 1, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Misonix, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261448?

K261448 is the FDA 510(k) for neXus Ultrasonic Surgical Aspirator System, submitted by Misonix, LLC. FDA's decision date was Jul 30, 2026, under product code LFL (Instrument, Ultrasonic Surgical).

Who makes the neXus Ultrasonic Surgical Aspirator System?

Misonix, LLC, based in Farmingdale, NY, is the applicant of record for K261448.

How long did the K261448 review take?

FDA received the submission on May 1, 2026 and issued its decision on Jul 30, 2026, 90 days later.

← All decisions in July 2026