# K173756: Certus 140 2.45GHz Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Neuwave Medical, Inc.
- Decided: Oct 24, 2018 after 317 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). 44 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160936: Certus 140 2.45GHz Ablation System, Neuwave Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K200081: NEUWAVE Microwave Ablation System and Accessories (2020), 2 descendants of its own
- K220472: NEUWAVE Microwave Ablation System and Accessories (2022), 1 descendant of its own
- K231738: NEUWAVE™ Microwave Ablation System and Accessories (2023), 0 descendants of its own

## Indications for use
The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors. The Certus 140™ 2.45 GHz Ablation System is not indicated for use in cardiac procedures. The system is designed for facility use and should only be used under the orders of a clinician.

Source page: https://510kreport.com/device/K173756
Methodology: https://510kreport.com/methodology