FDA.reportPublic FDA data

510(k) K221358

Device
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
Applicant
AtriCure, Inc.
510(k) number
K221358
Product code
OCL
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-30
Date received
2022-05-11
Regulation
878.4400
Classification name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jonathan McElwee
Address
7555 Innovation Way Mason OH US 45040 45040

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OCL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.2025-07-24
K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.2024-08-27
K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc.2022-12-22
K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.2021-07-26
K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.2021-05-28
K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic2020-06-03
K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.2019-12-13
K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.2019-11-04
K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.2019-10-01
K190587Coolrail Linear PenAtriCure, Inc.2019-07-24
K190623Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation DeviceMedtronic2019-05-30
K190151COBRA Fusion Ablation SystemAtriCure, Inc.2019-02-25
K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation DeviceMedtronic2018-12-19
K183065Coolrail Linear PenAtriCure, Inc.2018-12-04
K163408Isolator Multifunctional Linear PenAtriCure, Inc.2017-01-03