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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 / May 2026 / K254192

510(k) cleared

Senhance Ultrasonic System

Asensus Surgical · May 12, 2026 · K254192

FDA cleared the Senhance Ultrasonic System from Asensus Surgical on May 12, 2026 under K254192, a traditional 510(k). The device falls under product code NAY, System, Surgical, Computer Controlled Instrument, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 23, 2025. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Asensus Surgical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254192?

K254192 is the FDA 510(k) for Senhance Ultrasonic System, submitted by Asensus Surgical. FDA's decision date was May 12, 2026, under product code NAY (System, Surgical, Computer Controlled Instrument).

Who makes the Senhance Ultrasonic System?

Asensus Surgical, based in Durham, NC, is the applicant of record for K254192.

How long did the K254192 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on May 12, 2026, 140 days later.

← All decisions in May 2026