# K163118: FLEX Microwave Ablation System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Neuwave Medical, Inc.
- Decided: Mar 9, 2017 after 121 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: 12 generations back to K870028 (1987). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140, Neuwave Medical, Inc. (2010) Summary page 4.
- K113237: Certus 140 2.45GHZ Ablation System, Neuwave Medical, Inc. (2012) Summary page 4.
- K122217: Certus 140 2.45GHZ Ablation System, Neuwave Medical, Inc. (2012) Summary page 4.
- K130399: Certus 140 Certusurggt Surgical Tool, Neuwave Medical, Inc. (2013) Summary page 4.
- K160936: Certus 140 2.45GHz Ablation System, Neuwave Medical, Inc. (2016) Summary page 4.

## Indications for use
The NEUWAVE™ Flex Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue. The NEUWAVE™ Flex Microwave Ablation System is not indicated for use in cardiac procedures. The system is designed for facility use and should only be used under the orders of a physician.

Source page: https://510kreport.com/device/K163118
Methodology: https://510kreport.com/methodology