# K252632: Microwave Ablation Device

- Pathway: 510(k) (Traditional)
- Applicant: Nanjing Dewen Medical Technology Co., Ltd.
- Decided: Mar 2, 2026 after 194 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K870028 (1987). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232240: Microwave Ablation System (BD-GT), Betters (Suzhou) Medical Co., Ltd. (2023) Summary page 5.

## Indications for use
The Microwave Ablation Device is indicated for the coagulation (ablation) of soft tissue. The Microwave Ablation Device is not intended for cardiac use.

Source page: https://510kreport.com/device/K252632
Methodology: https://510kreport.com/methodology