Cleared Special

K071819 - NCONTACT VISITRAX GUIDED COAGULATION SY...

K071819 is an FDA 510(k) clearance for NCONTACT VISITRAX GUIDED COAGULATION SY..., manufactured by Ncontact Surgical, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Special 510(k) pathway after a 23-day FDA review.

K071819 · Ncontact Surgical, Inc. · Cardiovascular device
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Jul 2007
Decision
23d
Days
Class 2
Risk

K071819 is an FDA 510(k) clearance for the NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515. 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 July 26, 2007 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ncontact Surgical, Inc. devices

FDA 510(k) Submission Details - K071819

510(k) Number K071819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2007
Decision Date July 26, 2007
Days to Decision 23 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 K071819.
EPICOR ABLATION SYSTEM
K080292 · St Jude Medical · Jul 2008
CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE
K080509 · Medtronic, Inc. · May 2008
ATRICURE COOLRAIL LINEAR PEN
K073605 · AtriCure, Inc. · Mar 2008
ATRICURE BIPOLAR SYSTEM
K043579 · AtriCure, Inc. · Jul 2007
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
K070288 · Medtronic Vascular · Jun 2007
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
K061593 · AtriCure, Inc. · Jul 2006