# K200081: NEUWAVE Microwave Ablation System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Neuwave Medical, Inc.
- Decided: Nov 13, 2020 after 303 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: 13 generations back to K870028 (1987). 45 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173756: Certus 140 2.45GHz Ablation System, Neuwave Medical, Inc. (2018) Summary page 5.

## Most influential descendants
- K220472: NEUWAVE Microwave Ablation System and Accessories (2022), 1 descendant of its own
- K231738: NEUWAVE™ Microwave Ablation System and Accessories (2023), 0 descendants of its own

## Indications for use
The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors. The NEUWAVE Microwave Ablation System is not indicated for use in cardiac procedures.

Source page: https://510kreport.com/device/K200081
Methodology: https://510kreport.com/methodology