Cleared Special

K082279 - EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2

K082279 is an FDA 510(k) clearance for EPICOR ABLATION CONTROL SYSTEM, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Special 510(k) pathway after a 36-day FDA review.

K082279 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
36d
Days
Class 2
Risk

K082279 is an FDA 510(k) clearance for the EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2. Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by St Jude Medical (Sunnyvale, US). The FDA issued a Cleared decision on September 16, 2008 after a review of 36 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.

FDA 510(k) Submission Details - K082279

510(k) Number K082279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2008
Decision Date September 16, 2008
Days to Decision 36 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
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 53
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K082279.
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
K090721 · Medtronic · Jun 2009
NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
K090202 · Ncontact Surgical, Inc. · Feb 2009
NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021
K082203 · Ncontact Surgical, Inc. · Dec 2008
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
K082279 · EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
Download PDF FDA Summary St Jude Medical