Cleared Special

Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen

K192125 · AtriCure, Inc. · Cardiovascular

Nov 2019

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K192125 is an FDA 510(k) clearance for the Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen, 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 November 4, 2019, 90 days after receiving the submission on August 6, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K192125 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2019
Decision Date	November 04, 2019
Days to Decision	90 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