# K231738: NEUWAVE™ Microwave Ablation System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Neuwave Medical, Inc.
- Decided: Nov 16, 2023 after 155 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: 15 generations back to K870028 (1987). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220472: NEUWAVE Microwave Ablation System and Accessories, Neuwave Medical, Inc. (2022) Summary page 5.
- K200081: NEUWAVE Microwave Ablation System and Accessories, Neuwave Medical, Inc. (2020) Summary page 5.
- K130399: Certus 140 Certusurggt Surgical Tool, Neuwave Medical, Inc. (2013) Summary page 5.

## 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/K231738
Methodology: https://510kreport.com/methodology