# K122217: Certus 140 2.45GHZ Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Neuwave Medical, Inc.
- Decided: Dec 19, 2012 after 147 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: 9 generations back to K870028 (1987). 41 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 50 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 1.
- K113237: Certus 140 2.45GHZ Ablation System, Neuwave Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K130399: Certus 140 Certusurggt Surgical Tool (2013), 6 descendants of its own
- K160936: Certus 140 2.45GHz Ablation System (2016), 5 descendants of its own
- 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

## Indications for use
The NeuWave Medical Certus 140m 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 14OT' 2.45 GHz Ablation Systemi 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/K122217
Methodology: https://510kreport.com/methodology