Cleared Special

K082203 - NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021 (FDA 510(k) Clearance)

Also includes:
CSK-022 CSK-023 CSK-025

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082203 · Ncontact Surgical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 2008
Decision
147d
Days
Class 2
Risk

K082203 is an FDA 510(k) clearance for the NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021. 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 December 30, 2008 after a review of 147 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

Submission Details

510(k) Number K082203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2008
Decision Date December 30, 2008
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 53
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