# K061865: Flex 10 Mis Ablation Probe, Model FLX10MI-05

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Jul 27, 2006 after 24 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: 5 generations back to K811390 (1981). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013946: Flex 10 Accessory for the Afx Microwave Ablation System, Afx, Inc. (2002) Summary page 1.
- K041340: Guidant Microwave Ablation System, Guidant Corporation, Cardiac Surgery (2004) Summary page 1.

## Indications for use
The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.

Source page: https://510kreport.com/device/K061865
Methodology: https://510kreport.com/methodology