Cleared Traditional

Isolator? Linear Pen (MLP1); Isolator? Transpolar? Pen (MAX1, MAX5), Coolrail? Linear Pen (MCR1); Isolator? Synergy Surgical Ablation System (EMR2, EML2); Isolator? Synergy? EnCompass Clamp (OLH, OSH) and Guide System; Isolator? Synergy Access Clamp (EMT1)

K221358 · AtriCure, Inc. · Cardiovascular

Dec 2022

Decision

233d

Days

Class 2

Risk

About This 510(k) Submission

K221358 is an FDA 510(k) clearance for the Isolator? Linear Pen (MLP1); Isolator? Transpolar? Pen (MAX1, MAX5), Coolrail? Linear Pen (MCR1); Isolator? Synergy Surgical Ablation System (EMR2, EML2); Isolator? Synergy? EnCompass Clamp (OLH, OSH) and Guide System; Isolator? Synergy Access Clamp (EMT1), 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 December 30, 2022, 233 days after receiving the submission on May 11, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K221358 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2022
Decision Date	December 30, 2022
Days to Decision	233 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