# K252056: Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Jul 24, 2025 after 23 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)
- K210477: AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE, AtriCure, Inc. (2021) Summary page 5.

## Indications for use
The AtriCure Isolator Synergy EnCompass Clamp and Guide System is intended to ablate cardiac tissue during surgery.

Source page: https://510kreport.com/device/K252056
Methodology: https://510kreport.com/methodology