# K120857: Epi-Sense Guided Coagulation Device with Visitrax

- Pathway: 510(k) (Traditional)
- Applicant: Ncontact Surgical, Inc.
- Decided: Nov 13, 2012 after 237 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: 10 generations back to K942299 (1995). 57 ancestors in all.
2 later devices descend 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)
- K090202: Numeris Guided Coagulation System with Visitrax, Models CSK-121, -122, -123 and -125, Ncontact Surgical, Inc. (2009) Summary page 1.
- K113475: Estech Cobra Adhere XL 2 Surgical System, Endoscopic Technologies, Inc. D/B/A Estech (2012)

## Most influential descendants
- K142084: Epi-Sense Guided Coagulation Device with Visitrax (2014), 1 descendant of its own
- K193162: EPi-Sense Guided Coagulation System with VisiTrax (2019), 0 descendants of its own

## 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, endloscopic, 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/K120857
Methodology: https://510kreport.com/methodology