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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 / K252632

510(k) cleared

Microwave Ablation Device

Nanjing Dewen Medical Technology Co., Ltd. · Mar 2, 2026 · K252632

FDA cleared the Microwave Ablation Device from Nanjing Dewen Medical Technology Co., Ltd. on Mar 2, 2026 under K252632, a traditional 510(k). The device falls under product code NEY, System, Ablation, Microwave And Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 20, 2025. The decision came 194 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 Nanjing Dewen Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252632?

K252632 is the FDA 510(k) for Microwave Ablation Device, submitted by Nanjing Dewen Medical Technology Co., Ltd.. FDA's decision date was Mar 2, 2026, under product code NEY (System, Ablation, Microwave And Accessories).

Who makes the Microwave Ablation Device?

Nanjing Dewen Medical Technology Co., Ltd., based in Nanjing, is the applicant of record for K252632.

How long did the K252632 review take?

FDA received the submission on Aug 20, 2025 and issued its decision on Mar 2, 2026, 194 days later.

← All decisions in March 2026