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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
510(k) Number K142084
Device Name EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
Applicant
Ncontact Surgical, Inc.
1001 Aviation Pkwy., Suite 400
Morrisville,  NC  27560
Applicant Contact JANE RICUPERO
Correspondent
Ncontact Surgical, Inc.
1001 Aviation Pkwy., Suite 400
Morrisville,  NC  27560
Correspondent Contact JANE RICUPERO
Regulation Number878.4400
Classification Product Code
OCL  
Date Received07/31/2014
Decision Date 10/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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