# K240480: IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jul 19, 2024 after 150 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: 14 generations back to K870028 (1987). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200796: Emprint Ablation System with Thermosphere Technology, Covidien, LLC (2020) Summary page 5.
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140, Neuwave Medical, Inc. (2010) Summary page 5.

## Indications for use
IntelliBlate Microwave Ablation System: The IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Microwave Ablation System is not intended for use in cardiac procedures. IntelliBlate Ximitry Probe Assembly: The IntelliBlate Ximitry Probe Assembly, used with the IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Ximitry Probe Assembly is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K240480
Methodology: https://510kreport.com/methodology
