Cleared Traditional

K142084 - EPI-SENSE GUIDED COAGULATION DEVICE WIT...

K142084 is an FDA 510(k) clearance for EPI-SENSE GUIDED COAGULATION DEVICE WIT..., manufactured by Ncontact Surgical, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K142084 · Ncontact Surgical, Inc. · Cardiovascular device
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Oct 2014
Decision
89d
Days
Class 2
Risk

K142084 is an FDA 510(k) clearance for the EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX. Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by Ncontact Surgical, Inc. (Morrisville, US). The FDA issued a Cleared decision on October 28, 2014 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ncontact Surgical, Inc. devices

FDA 510(k) Submission Details - K142084

510(k) Number K142084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2014
Decision Date October 28, 2014
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCL Device Classification - Class 2, Special Controls

Product Code OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

All 38
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K142084.
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