Cleared Traditional

K120857 - EPI-SENSE GUIDED COAGULATION DEVICE WIT...

K120857 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 237-day FDA review.

K120857 · Ncontact Surgical, Inc. · Cardiovascular device
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Nov 2012
Decision
237d
Days
Class 2
Risk

K120857 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 November 13, 2012 after a review of 237 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ncontact Surgical, Inc. devices

FDA 510(k) Submission Details - K120857

510(k) Number K120857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2012
Decision Date November 13, 2012
Days to Decision 237 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
112d slower than avg
Panel avg: 125d · This submission: 237d
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 K120857.
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CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
K121878 · Medtronic, Inc. · Nov 2012
COOLRAIL LINEAR PEN MODEL MCRI
K122611 · AtriCure, Inc. · Sep 2012
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · Medtronic, Inc. · Jul 2012