# K063630: Atricure Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Jan 26, 2007 after 51 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: 8 generations back to K942299 (1995). 41 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 49 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)
- K052893: Atricure Transpolar System, AtriCure, Inc. (2005) Summary page 1.
- K060400: Cardioblate Surgical  Ablation Generator, Model 68000; Cardioblate BP2 Surgical Ablation Device, Model 60831; Cardioblat, Medtronic, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K210477: AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (2021), 2 descendants of its own
- K211311: AtriCure Isolator® Synergy™ Surgical Ablation System (2021), 2 descendants of its own
- K252056: Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (2025), 0 descendants of its own

## Indications for use
The AtriCure Ablation System is intended to ablate soft tissues during general surgery using radiofrequency energy.

Source page: https://510kreport.com/device/K063630
Methodology: https://510kreport.com/methodology