# K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jul 17, 2003 after 90 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & 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: 6 generations back to K942299 (1995). 38 ancestors in all.
34 later devices descend from it; 4 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880, Medtronic Vascular (2002)
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1, AtriCure, Inc. (2002)

## Most influential descendants
- K060054: Oncobionic System (2006), 14 descendants of its own
- K060400: Cardioblate Surgical  Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation Device, Model 60831; Cardioblat (2006), 14 descendants of its own
- K080202: Oncobionic System with 6 Probe Output (2008), 11 descendants of its own
- K080376: Oncobionic System (2008), 11 descendants of its own
- K102329: Nanoknife System (2011), 10 descendants of its own

## Indications for use
The Medtronim CardioblateB Bipolar Radiofrequency Ablation System is intended to ablate soft tissue during general surgery using radiofrequency energy.

Source page: https://510kreport.com/device/K031247
Methodology: https://510kreport.com/methodology