# K193162: EPi-Sense Guided Coagulation System with VisiTrax

- Pathway: 510(k) (Special)
- Applicant: AtriCure, Inc.
- Decided: Dec 13, 2019 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: 12 generations back to K942299 (1995). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142084: Epi-Sense Guided Coagulation Device with Visitrax, Ncontact Surgical, Inc. (2014) Summary page 4.

## Indications for use
The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques. The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.

Source page: https://510kreport.com/device/K193162
Methodology: https://510kreport.com/methodology