# K233140: Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)

- Pathway: 510(k) (Traditional)
- Applicant: Hygea Medical Technology Co., Ltd.
- Decided: Jan 31, 2024 after 126 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: 12 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)
- K201262: Microwave Therapeutic System, Nanjing Eco Microwave System Co., Ltd. (2021) Summary page 5.
- K201265: Disposable Microwave Therapeutic Antennas, Nanjing Eco Microwave System Co., Ltd. (2021) Summary page 5.

## Indications for use
The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use. Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.

Source page: https://510kreport.com/device/K233140
Methodology: https://510kreport.com/methodology