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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 / K260351

510(k) cleared

Numen Helia Coil Embolization System; NumenFR Detachment System

MicroPort NeuroTech (Shanghai) Co., Ltd. · May 20, 2026 · K260351

FDA cleared the Numen Helia Coil Embolization System; NumenFR Detachment System from MicroPort NeuroTech (Shanghai) Co., Ltd. on May 20, 2026 under K260351, a special 510(k). The device falls under product code HCG, Device, Neurovascular Embolization, regulated at 21 CFR 882.5950 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 3, 2026. The decision came 106 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 MicroPort NeuroTech (Shanghai) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260351?

K260351 is the FDA 510(k) for Numen Helia Coil Embolization System; NumenFR Detachment System, submitted by MicroPort NeuroTech (Shanghai) Co., Ltd.. FDA's decision date was May 20, 2026, under product code HCG (Device, Neurovascular Embolization).

Who makes the Numen Helia Coil Embolization System; NumenFR Detachment System?

MicroPort NeuroTech (Shanghai) Co., Ltd., based in Shanghai, is the applicant of record for K260351.

How long did the K260351 review take?

FDA received the submission on Feb 3, 2026 and issued its decision on May 20, 2026, 106 days later.

← All decisions in May 2026