# K050223: Vivawave Microwave Ablation System, Coaxial Introducer

- Pathway: 510(k) (Special)
- Applicant: Vivant Medical, Inc.
- Decided: Feb 24, 2005 after 24 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K041167: Pioneer Surgical Technology Quantum Spinal System, Pioneer Surgical Technology (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K081042: Microthermx-100 Microwave Ablation System and Accessories (2008), 2 descendants of its own
- K100786: Microthermx Microwave Ablation System, Models MTX-180 or MTX (2010), 1 descendant of its own
- K141785: Micro Thermx Microwave Ablation System and Accessories (2015), 0 descendants of its own

## Indications for use
The VivaWave TM Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K050223
Methodology: https://510kreport.com/methodology