# K211311: AtriCure Isolator® Synergy™ Surgical Ablation System

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: May 28, 2021 after 28 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: 11 generations back to K942299 (1995). 60 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110117: Atricure Bipolar System, AtriCure, Inc. (2011) Summary page 4.

## Most influential descendants
- 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 Isolator Synergy Surgical Ablation System is intended to ablate cardiac tissue during surgery.

Source page: https://510kreport.com/device/K211311
Methodology: https://510kreport.com/methodology