# K162449: Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: May 5, 2017 after 246 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K094021 (2010). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122762: Acculis ACCU21 Pmta Microwave Tissue Ablation Applicator, Microsulis Medical Limited (2012) Summary page 5.

## Most influential descendants
- K213067: Solero Microwave Tissue Ablation (MTA) System and Accessories (2021), 2 descendants of its own
- 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
- K182250: Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) (2019), 0 descendants of its own

## Recalls of this device
- Jul 20, 2021 · Class II · Z-2436-2021: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
- Jul 20, 2021 · Class II · Z-2439-2021: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
- Jul 20, 2021 · Class II · Z-2438-2021: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
- Jul 20, 2021 · Class II · Z-2437-2021: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
- Apr 17, 2019 · Class II · Z-1701-2019: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
- Apr 17, 2019 · Class II · Z-1700-2019: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
- Apr 17, 2019 · Class II · Z-1703-2019: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
- Apr 17, 2019 · Class II · Z-1704-2019: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
- Apr 17, 2019 · Class II · Z-1702-2019: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

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

Source page: https://510kreport.com/device/K162449
Methodology: https://510kreport.com/methodology