Cleared Traditional

Isolator Synergy EnCapture Ablation System (EMH)

K234151 · AtriCure, Inc. · Cardiovascular

Aug 2024

Decision

242d

Days

Class 2

Risk

About This 510(k) Submission

K234151 is an FDA 510(k) clearance for the Isolator Synergy EnCapture Ablation System (EMH), 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 August 27, 2024, 242 days after receiving the submission on December 29, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K234151 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2023
Decision Date	August 27, 2024
Days to Decision	242 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