Cleared Special

AtriCure Isolator? Synergy? Surgical Ablation System

K211311 · AtriCure, Inc. · Cardiovascular

May 2021

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K211311 is an FDA 510(k) clearance for the AtriCure Isolator? Synergy? Surgical Ablation System, a Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (Class II — Special Controls, product code OCL), submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on May 28, 2021, 28 days after receiving the submission on April 30, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K211311 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OCL — Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue