Cleared Special

K163408 - Isolator Multifunctional Linear Pen

K163408 is an FDA 510(k) clearance for Isolator Multifunctional Linear Pen, manufactured by AtriCure, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Special 510(k) pathway after a 29-day FDA review.

K163408 · AtriCure, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
29d
Days
Class 2
Risk

K163408 is an FDA 510(k) clearance for the Isolator 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. (Mason, US). The FDA issued a Cleared decision on January 3, 2017 after a review of 29 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 - K163408

510(k) Number K163408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2016
Decision Date January 03, 2017
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K163408.
COBRA Fusion Ablation System
K190151 · AtriCure, Inc. · Feb 2019
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
K182610 · Medtronic · Dec 2018
Coolrail Linear Pen
K183065 · AtriCure, Inc. · Dec 2018
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K142084 · Ncontact Surgical, Inc. · Oct 2014
ISOLATOR LINEAR PEN
K130521 · AtriCure, Inc. · Apr 2013
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
K123733 · Medtronic, Inc. · Apr 2013
K163408 · Isolator Multifunctional Linear Pen
Download PDF FDA Summary AtriCure, Inc.