# K213067: Solero Microwave Tissue Ablation (MTA) System and Accessories

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Dec 3, 2021 after 71 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: 3 generations back to K094021 (2010). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162449: Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm), AngioDynamics, Inc. (2017) Summary page 4.

## Most influential descendants
- K223581: Solero Microwave Tissue Ablation (MTA) System and Accessories (2023), 0 descendants of its own
- K221883: Solero Microwave Tissue Ablation (MTA) System and Accessories (2023), 0 descendants of its own

## Indications for use
The Solero Microwave Tissue Ablation (MTA) System and Accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

Source page: https://510kreport.com/device/K213067
Methodology: https://510kreport.com/methodology