# K110117: Atricure Bipolar System

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Apr 8, 2011 after 80 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: 10 generations back to K942299 (1995). 59 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 65 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.
- K052893: Atricure Transpolar System, AtriCure, Inc. (2005) Summary page 1.
- K063630: Atricure Ablation System, AtriCure, Inc. (2007) Summary page 1.
- K043579: Atricure Bipolar System, AtriCure, Inc. (2007) Summary page 1.
- K101174: Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model OLL2, OSL2, EMR2, EML2, AtriCure, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- K234151: Isolator Synergy EnCapture Ablation System (EMH) (2024), 0 descendants of its own
- K221358: Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) (2022), 0 descendants of its own

## Indications for use
The AtriCure Bipolar System is intended for the ablation of caridac tissue during surgery.

Source page: https://510kreport.com/device/K110117
Methodology: https://510kreport.com/methodology