# K160936: Certus 140 2.45GHz Ablation System

- Pathway: 510(k) (Special)
- Applicant: Neuwave Medical, Inc.
- Decided: May 4, 2016 after 30 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: 11 generations back to K870028 (1987). 43 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140, Neuwave Medical, Inc. (2010) Summary page 4.
- K113237: Certus 140 2.45GHZ Ablation System, Neuwave Medical, Inc. (2012) Summary page 4.
- K122217: Certus 140 2.45GHZ Ablation System, Neuwave Medical, Inc. (2012) Summary page 4.
- K130399: Certus 140 Certusurggt Surgical Tool, Neuwave Medical, Inc. (2013) Summary page 4.

## Most influential descendants
- K173756: Certus 140 2.45GHz Ablation System (2018), 3 descendants of its own
- 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
- K163118: FLEX Microwave Ablation System and Accessories (2017), 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. 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/K160936
Methodology: https://510kreport.com/methodology