# K053535: Vivawave Microwave Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab
- Decided: Apr 27, 2006 after 129 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: 2 generations back to K861904 (1986). 6 ancestors in all.
50 later devices descend from it; 6 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011676: Vivawave Microwave System, Vivant Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140 (2010), 39 descendants of its own
- 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

## Indications for use
The VivaWaveTM Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The VivaWave TM Microwave Ablation System is not intended for use in cardiac procedures. Valleylab recommends against the use of microwave ablation in the following situations: * Pregnant patients - potential risks to the patient and/or fetus have not been established. * Patients with implantable pacemakers and other electronic implants. Implanted electronic devices may be adversely affected by microwave power output.

Source page: https://510kreport.com/device/K053535
Methodology: https://510kreport.com/methodology