# K094021: Acculis ACCU2I Pmta Applicator Model ACCU2I

- Pathway: 510(k) (Traditional)
- Applicant: Microsulis Medical Limited
- Decided: Aug 6, 2010 after 219 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K122762: Acculis ACCU21 Pmta Microwave Tissue Ablation Applicator (2012), 5 descendants of its own
- K162449: Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) (2017), 4 descendants of its own
- 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

## Recalls of this device
- Jun 5, 2017 · Class II · Z-0529-2018: The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electric
- Jun 5, 2017 · Class II · Z-0531-2018: The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electric
- Jun 5, 2017 · Class II · Z-0526-2018: The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electric
- Jun 5, 2017 · Class II · Z-0528-2018: The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electric
- Jun 5, 2017 · Class II · Z-0527-2018: The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electric
- Jun 5, 2017 · Class II · Z-0530-2018: The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electric

## Indications for use
The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Source page: https://510kreport.com/device/K094021
Methodology: https://510kreport.com/methodology