# K223581: Solero Microwave Tissue Ablation (MTA) System and Accessories

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Mar 27, 2023 after 116 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: 4 generations back to K094021 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213067: Solero Microwave Tissue Ablation (MTA) System and Accessories, AngioDynamics, Inc. (2021) Summary page 4.

## 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/K223581
Methodology: https://510kreport.com/methodology