# K192406: AveCure BT Microwave Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Medwaves, Inc.
- Decided: Nov 25, 2020 after 448 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: 10 generations back to K943450 (1995). 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)
- K161949: OsteoCool V-3 RF Ablation System, Baylis Medical Company, Inc. (2017) Summary page 4.

## Indications for use
The AveCure BT Microwave Ablation System is intended for: » Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. » Coagulation and ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

Source page: https://510kreport.com/device/K192406
Methodology: https://510kreport.com/methodology