# K070356: Medwaves Microwave Coagulation/Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Medwaves Incorporated
- Decided: Dec 18, 2007 after 315 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: 6 generations back to K861904 (1986). 18 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052919: Microsulis Tissue Ablation System, Microsulis Americas, Inc. (2006) Summary page 1.
- K984552: Cool-Tip RF System, Radionics, Inc. (1999) Summary page 1.
- K011676: Vivawave Microwave System, Vivant Medical, Inc. (2002) Summary page 1.
- K053535: Vivawave Microwave Ablation System, Valleylab (2006) Summary page 1.

## Most influential descendants
- K083537: Modification to Medwaves Microwave Coagulation/Ablation System (2009), 1 descendant of its own
- K143203: AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe (2015), 0 descendants of its own

## Indications for use
The MedWaves Microwave Coagulation/Ablation System is intended for general surgery use in open procedures for the coagulation and ablation of soft tissues. The system is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K070356
Methodology: https://510kreport.com/methodology