# K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140

- Pathway: 510(k) (Traditional)
- Applicant: Neuwave Medical, Inc.
- Decided: Oct 22, 2010 after 220 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: 7 generations back to K870028 (1987). 39 ancestors in all.
39 later devices descend from it; 6 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072687: Valleylab Microwave Ablation Generator, Covidien Lp, Formerly Know AS Valleylab, A Divison (2008) Summary page 1.
- K053535: Vivawave Microwave Ablation System, Valleylab (2006) Summary page 1.
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 1.
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 1.
- K023757: Cryocare Surgical System, Model Cryo 20, Endocare, Inc. (2002) Summary page 1.
- K070023: Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100, Microsurgeon, Inc. (2007) Summary page 1.
- K000241: Radiotherapeutics RF 3000 Radiofrequency Generator, Radiotherapeutics Corp. (2000) Summary page 1.

## Most influential descendants
- K113237: Certus 140 2.45GHZ Ablation System (2012), 38 descendants of its own
- K133821: Emprint Ablation System (2014), 29 descendants of its own
- K163105: Emprint Ablation System (2016), 13 descendants of its own
- K183153: Microwave Ablation System (2019), 9 descendants of its own
- K122217: Certus 140 2.45GHZ Ablation System (2012), 8 descendants of its own

## Indications for use
The NeuWave Medical Certus 140 2.45 0Hz Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue. The Gertus 140 2.45 GHz Ablation System is not intended for use in cardiac procedures. NeuWave recommends against the use of the Certus 140 2.45 0Hz Ablation System in the following situations: * Pregnant patients - potential risks to patient and/or fetus have not been established * Patients with implantable pacemakers or other electronic implants. Implanted electronic devices may be adversely affected by microwave power The system is designed for facility use and should only be used under the orders of a clinician.

Source page: https://510kreport.com/device/K100744
Methodology: https://510kreport.com/methodology