Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)— 510(k) K253771

Name: FDA 510(k) clearance K253771
Creator: U.S. Food and Drug Administration
Published: 2026-03-02

Substantially Equivalent

Nanjing Devin Medical Technology Co., Ltd.

FDA 510(k) clearance K253771 for Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13), Substantially Equivalent on 2026-03-02. Applicant: Nanjing Devin Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nanjing Devin Medical Technology Co., Ltd.
Product code: Code NEY
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2025-11-26
Decision date: 2026-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

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K241827 — Microwave Ablation Generator (KY-2000A, KY-2100A)2024-09-26
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K240480 — IntelliBlate Microwave Ablation System Console (IB-CON) +4 more2024-07-19

Adverse events under product code NEY

product code NEY

Death: 24
Injury: 388
Malfunction: 462
Other: 1
Total: 875

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.