FDA 510(k) clearance · back to tracker

Microwave Ablation Device

Nanjing Dewen Medical Technology Co., Ltd. cleared K252632 on 2026-03-02, decision: substantially equivalent

K-number

K252632

Sponsor

Nanjing Dewen Medical Technology Co., Ltd.

Device

Microwave Ablation Device

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-03-02

Product code

NEY

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K252632on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.