# K183153: Microwave Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Decided: Jul 8, 2019 after 236 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: 10 generations back to K870028 (1987). 42 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133821: Emprint Ablation System, Covidien, LLC (2014) Summary page 4.

## Most influential descendants
- K201265: Disposable Microwave Therapeutic Antennas (2021), 4 descendants of its own
- K201262: Microwave Therapeutic System (2021), 4 descendants of its own
- K232240: Microwave Ablation System (BD-GT) (2023), 1 descendant of its own
- K232241: Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) (2023), 1 descendant of its own
- K252632: Microwave Ablation Device (2026), 0 descendants of its own

## Indications for use
The Microwave Ablation System is intended for coagulation (ablation) of soft tissue. It is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K183153
Methodology: https://510kreport.com/methodology