510(k) Report

Devices descending from K101174

6 later devices reach Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110117Atricure Bipolar SystemAtriCure, Inc.20115—
+2K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—
+2K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.20212—
+2K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.20212—
+3K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.20250—
+3K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—