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FDA 510(k)

Microwave Ablation Device

K-Number: K252632 · 2026-03-02

ApplicantNanjing Dewen Medical Technology Co., Ltd.
Decision Date2026-03-02
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Microwave Ablation Device is a medical device manufactured by Nanjing Dewen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-02 under approval number K252632. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Microwave Ablation Device?

Microwave Ablation Device is a medical device that received FDA 510(k) clearance on 2026-03-02. It is manufactured by Nanjing Dewen Medical Technology Co., Ltd.. The 510(k) number is K252632.

When was Microwave Ablation Device approved by the FDA?

Microwave Ablation Device received FDA 510(k) clearance on 2026-03-02, under approval number K252632.

What company makes Microwave Ablation Device?

Microwave Ablation Device is manufactured by Nanjing Dewen Medical Technology Co., Ltd..

What is the FDA product code for Microwave Ablation Device?

The FDA product code for Microwave Ablation Device is NEY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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