EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX

Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

NCONTACT SURGICAL, INC.

The following data is part of a premarket notification filed by Ncontact Surgical, Inc. with the FDA for Epi-sense Guided Coagulation Device With Visitrax.

Pre-market Notification Details

Device IDK142084
510k NumberK142084
Device Name:EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
ClassificationSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Applicant NCONTACT SURGICAL, INC. 1001AVIATION PARKWAY, SUITE 400 Morrisville,  NC  27560
ContactJane Ricupero
CorrespondentJane Ricupero
NCONTACT SURGICAL, INC. 1001AVIATION PARKWAY, SUITE 400 Morrisville,  NC  27560
Product CodeOCL  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-31
Decision Date2014-10-28
Summary:summary

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