# K142084: Epi-Sense Guided Coagulation Device with Visitrax

- Pathway: 510(k) (Traditional)
- Applicant: Ncontact Surgical, Inc.
- Decided: Oct 28, 2014 after 89 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K942299 (1995). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120857: Epi-Sense Guided Coagulation Device with Visitrax, Ncontact Surgical, Inc. (2012) Summary page 4.

## Most influential descendants
- K193162: EPi-Sense Guided Coagulation System with VisiTrax (2019), 0 descendants of its own

## Recalls of this device
- May 29, 2019 · Class II · Z-1887-2019: The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.

## 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/K142084
Methodology: https://510kreport.com/methodology