# K234151: Isolator Synergy EnCapture Ablation System (EMH)

- Pathway: 510(k) (Traditional)
- Applicant: AtriCure, Inc.
- Decided: Aug 27, 2024 after 242 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: 12 generations back to K942299 (1995). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211311: AtriCure Isolator® Synergy™ Surgical Ablation System, AtriCure, Inc. (2021) Summary page 5.

## Indications for use
The AtriCure Isolator Synergy EnCapture Clamp is intended to ablate cardiac tissue during surgery.

Source page: https://510kreport.com/device/K234151
Methodology: https://510kreport.com/methodology