# K022894: Epicor Medical Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Epicor Medical, Inc.
- Decided: Feb 26, 2004 after 541 days
- Product code: NTB (System, Ablation, Ultrasound 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: 6 generations back to K942299 (1995). 47 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010956: Cobra 1/2 Flex Surgical Probe, Model 1593X; Cobra Flex Surgical Probe Model 1594X, Boston Scientific Corp (2001)
- K013873: Cobra Cardiac Electrosurgical System, Boston Scientific Corp (2002) Summary page 4.
- K011722: Atricure Bipolar Coagulation System, AtriCure, Inc. (2001)
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1, AtriCure, Inc. (2002) Summary page 4.
- K003978: Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N 102006, P/N 102007, Afx, Inc. (2001) Summary page 4.
- K013946: Flex 10 Accessory for the Afx Microwave Ablation System, Afx, Inc. (2002) Summary page 4.
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880, Medtronic Vascular (2002)
- K013901: Malleable Surgical Lightstic 180, Model 180 (1CM-9CM), Cardiofocus, Inc. (2001) Summary page 4.
- K022008: Cardima Ablation System, Cardima, Inc. (2003). Cleared while this submission was under review Summary page 4.

## Cited in the summary but kept off the family tree
- K021010: Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE, Endocare, Inc. (2002). Our reading of the summary gave K021010, FDA’s number for Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSE (Endocare, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CryoCath SurgiFrost probe”. Kept off the family tree. Summary page 4.

## Most influential descendants
- 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 (2004), 22 descendants of its own
- K043579: Atricure Bipolar System (2007), 18 descendants of its own
- K080509: Cardioblate 68000 Gnerator, BP2 Surgical Ablation Device, LP Surgical Ablation Device, Gemini-Ssurgical Ablation Device (2008), 10 descendants of its own
- K101174: Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2 (2010), 6 descendants of its own
- K110117: Atricure Bipolar System (2011), 5 descendants of its own

## Indications for use
The Epicor Medical Ablation System (the UltraWand Ablation Device, Ablation Control System, and Connecting Cable) is Intended for the ablation of cardiac tissue during cardiac surgery.

Source page: https://510kreport.com/device/K022894
Methodology: https://510kreport.com/methodology