Cleared Traditional

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

K210477 · AtriCure, Inc. · Cardiovascular

Jul 2021

Decision

157d

Days

Class 2

Risk

About This 510(k) Submission

K210477 is an FDA 510(k) clearance for the AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE, 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 July 26, 2021, 157 days after receiving the submission on February 19, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K210477 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2021
Decision Date	July 26, 2021
Days to Decision	157 days
Submission Type	Traditional
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