# K043579: Atricure Bipolar System

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Jul 5, 2007 after 919 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K942299 (1995). 53 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1, AtriCure, Inc. (2002) Summary page 1.
- K013392: Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880, Medtronic Vascular (2002) Summary page 1.
- K013873: Cobra Cardiac Electrosurgical System, Boston Scientific Corp (2002) Summary page 1.
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console, Cryocath Technologies, Inc. (2004) 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.
- 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
- 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
- K093203: Cardioblate Bipolar Radiofrequency Surgical Ablation System, Models 60831, 60832, 60841 (2010), 3 descendants of its own
- K210477: AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (2021), 2 descendants of its own

## Indications for use
The AtriCure Bipolar (Transpolar)System is intended for the ablation of cardiac tissue during surgery.

Source page: https://510kreport.com/device/K043579
Methodology: https://510kreport.com/methodology