Cleared Traditional

K100501 - MULTIFUNCTIONAL LINEAR PEN

K100501 is an FDA 510(k) clearance for MULTIFUNCTIONAL LINEAR PEN, manufactured by AtriCure, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K100501 · AtriCure, Inc. · Cardiovascular device
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Jun 2010
Decision
116d
Days
Class 2
Risk

K100501 is an FDA 510(k) clearance for the MULTIFUNCTIONAL LINEAR PEN. 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 June 18, 2010 after a review of 116 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all AtriCure, Inc. devices

FDA 510(k) Submission Details - K100501

510(k) Number K100501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2010
Decision Date June 18, 2010
Days to Decision 116 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
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 43
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K100501.
ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
K110913 · Endoscopic Technologies, Inc. D/B/A Estech · Sep 2011
ATRICURE BIPOLAR SYSTEM
K110117 · AtriCure, Inc. · Apr 2011
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
K101174 · AtriCure, Inc. · Nov 2010
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
K090721 · Medtronic · Jun 2009
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
K082279 · St Jude Medical · Sep 2008
EPICOR ABLATION SYSTEM
K080292 · St Jude Medical · Jul 2008