# K080292: Epicor Ablation System

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jul 25, 2008 after 172 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942299 (1995). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022894: Epicor Medical Ablation System, Epicor Medical, Inc. (2004) Summary page 1.
- K040641: Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-Acc-1, Epicor Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K082279: Epicor Ablation Control System, Model Acs-US-2, Acs-Eur-2 (2008), 0 descendants of its own

## Recalls of this device
- Jun 15, 2009 · Not classified · Z-1780-2010: The firm states that overheating of cardiac tissue is caused by inadequate cooling. The potential exists when the UltraWand is run using off-label cooling methods (gravity saline flow instead of pump)
- Dec 9, 2008 · Not classified · Z-0946-2009: Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit

## Indications for use
The Epicor Medical Ablation Control System is intended for the ablation of cardiac tissue during cardiac surgery The UltraCinch LP is intended for the ablation of cardiac tissue during cardiac surgery The UltraWand LP is intended for the ablation of cardiac tissue during cardiac surgery The items in LP PAS System are part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery The LP Oblique Introducer is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery The LP Connecting Cable is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery

Source page: https://510kreport.com/device/K080292
Methodology: https://510kreport.com/methodology