Cleared Special

K080292 - EPICOR ABLATION SYSTEM

K080292 is an FDA 510(k) clearance for EPICOR ABLATION 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 172-day FDA review.

K080292 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
172d
Days
Class 2
Risk

K080292 is an FDA 510(k) clearance for the EPICOR ABLATION SYSTEM. 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 (St. Paul, US). The FDA issued a Cleared decision on July 25, 2008 after a review of 172 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. 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.

FDA 510(k) Submission Details - K080292

510(k) Number K080292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2008
Decision Date July 25, 2008
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
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 K080292.
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 CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
K082279 · St Jude Medical · Sep 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
NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
K071819 · Ncontact Surgical, Inc. · Jul 2007
K080292 · EPICOR ABLATION SYSTEM
Download PDF FDA Summary St Jude Medical