Cleared Traditional

K110117 - ATRICURE BIPOLAR SYSTEM

K110117 is the FDA 510(k) clearance for ATRICURE BIPOLAR SYSTEM by AtriCure, Inc.. It is a Class 2 Cardiovascular device (product code OCL) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K110117 · AtriCure, Inc. · Cardiovascular device
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Apr 2011
Decision
80d
Days
Class 2
Risk

K110117 is an FDA 510(k) clearance for the ATRICURE BIPOLAR 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 AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on April 8, 2011 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K110117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2011
Decision Date April 08, 2011
Days to Decision 80 days
Submission Type Traditional
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
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 33
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K110117.
COOLRAIL LINEAR PEN MODEL MCRI
K122611 · AtriCure, Inc. · Sep 2012
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · Medtronic, Inc. · Jul 2012
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
K121451 · Medtronic, Inc. · Jun 2012
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
K101174 · AtriCure, Inc. · Nov 2010
MULTIFUNCTIONAL LINEAR PEN
K100501 · AtriCure, Inc. · Jun 2010
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
K082279 · St Jude Medical · Sep 2008