EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX— 510(k) K142084

Clearance details

Applicant

Ncontact Surgical, Inc.

Product code

Code OCL

Device class

Class 2

Regulation

21 CFR 878.4400

Advisory panel

General, Plastic Surgery

Date received

2014-07-31

Decision date

2014-10-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Morrisville, NC, US

• K252056 — Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)2025-07-24
• K234151 — Isolator Synergy EnCapture Ablation System (EMH)2024-08-27
• K221358 — Isolator® Linear Pen (MLP1) +4 more2022-12-30
• K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device2022-12-22
• K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE2021-07-26

• K120857 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX2012-11-13
• K090202 — NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -1252009-02-17
• K082203 — NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021; CSK-022; CSK-023; CSK-0252008-12-30
• K071819 — NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-5152007-07-26
• K062539 — NCONTACT COAGULATION SYSTEM KIT2006-12-01

Death

34

Injury

256

Total

290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1887-2019 — EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.Class II·Terminated·AtriCure, Inc.·20190529

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142084.