Cleared Special

K211311 - AtriCure Isolator® Synergy™ Surgical Ablation System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K211311 · AtriCure, Inc. · Cardiovascular device
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May 2021
Decision
28d
Days
Class 2
Risk

K211311 is an FDA 510(k) clearance for the AtriCure Isolator® Synergy™ Surgical 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 AtriCure, Inc. (Mason, US). The FDA issued a Cleared decision on May 28, 2021 after a review of 28 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.

View all AtriCure, Inc. devices

Submission Details

510(k) Number K211311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2021
Decision Date May 28, 2021
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 53
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K211311.
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
K252056 · AtriCure, Inc. · Jul 2025
Isolator Synergy EnCapture Ablation System (EMH)
K234151 · AtriCure, Inc. · Aug 2024
Isolator® Linear Pen (MLP1)
K221358 · AtriCure, Inc. · Dec 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
K223508 · Medtronic, Inc. · Dec 2022
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
K210477 · AtriCure, Inc. · Jul 2021