# K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880

- Pathway: 510(k) (Abbreviated)
- Applicant: Medtronic Vascular
- Decided: Jan 25, 2002 after 102 days
- Product code: OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921884 (1992). 5 ancestors in all.
102 later devices descend from it; 12 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010662: Modification to Tissuelink Monopolar Floating Ball, Tissuelink Medical, Inc. (2001) Summary page 1.
- K010956: Cobra 1/2 Flex Surgical Probe, Model 1593X; Cobra Flex Surgical Probe Model 1594X, Boston Scientific Corp (2001) Summary page 1.
- K011040: Cryocare Cardiac Surgical System, Endocare, Inc. (2001) Summary page 1.
- K003978: Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007, Afx, Inc. (2001) Summary page 1.
- K921884: FORCE 2, Valleylab, Inc. (1992) Summary page 1.

## Most influential descendants
- K013873: Cobra Cardiac Electrosurgical System (2002), 61 descendants of its own
- K023288: Cobra Bipolar Clamp, Model 15902 (2003), 46 descendants of its own
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 descendants of its own
- K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System (2003), 34 descendants of its own
- K022008: Cardima Ablation System (2003), 25 descendants of its own

## Recalls of this device
- Nov 11, 2002 · Not classified · Z-0351-03: The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device.

## Indications for use
The Medtronic® Cardioblate™ Radiofrequency Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Source page: https://510kreport.com/device/K013392
Methodology: https://510kreport.com/methodology