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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 / August 2026 / K260559

510(k) cleared

NHanceIT

IMDS Operation B.V. · Aug 14, 2026 · K260559

FDA cleared the NHanceIT from IMDS Operation B.V. on Aug 14, 2026 under K260559, a traditional 510(k). The device falls under product code DQY, Catheter, Percutaneous, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 19, 2026. The decision came 176 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 IMDS Operation B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260559?

K260559 is the FDA 510(k) for NHanceIT, submitted by IMDS Operation B.V.. FDA's decision date was Aug 14, 2026, under product code DQY (Catheter, Percutaneous).

Who makes the NHanceIT?

IMDS Operation B.V., based in Roden, is the applicant of record for K260559.

How long did the K260559 review take?

FDA received the submission on Feb 19, 2026 and issued its decision on Aug 14, 2026, 176 days later.

← All decisions in August 2026