OCL · Class II · 21 CFR 878.4400

FDA Product Code OCL: Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

Under FDA product code OCL, surgical devices that combine cutting, coagulation, and ablation functions are cleared for multi-modal tissue treatment.

These advanced energy platforms integrate multiple energy modalities — such as radiofrequency and microwave — into a single device capable of performing tissue cutting, hemostasis, and ablation in a single instrument. They are used in cardiac surgery and interventional procedures.

OCL devices are Class II medical devices, regulated under 21 CFR 878.4400 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include AtriCure, Inc., Medtronic, Inc. and Medtronic.

54
Total
54
Cleared
105d
Avg days
1997
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 23d recently vs 107d historically

FDA 510(k) Cleared Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue Devices (Product Code OCL)

54 devices
1–24 of 54
Cleared Jul 24, 2025
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
K252056
AtriCure, Inc.
Cardiovascular · 23d
Cleared Aug 27, 2024
Isolator Synergy EnCapture Ablation System (EMH)
K234151
AtriCure, Inc.
Cardiovascular · 242d
Cleared Dec 30, 2022
Isolator® Linear Pen (MLP1)
K221358
AtriCure, Inc.
Cardiovascular · 233d
Cleared Dec 22, 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
K223508
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jul 26, 2021
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
K210477
AtriCure, Inc.
Cardiovascular · 157d
Cleared May 28, 2021
AtriCure Isolator® Synergy™ Surgical Ablation System
K211311
AtriCure, Inc.
Cardiovascular · 28d
Cleared Jun 03, 2020
Cardioblate Gemini-s Surgical Ablation Device
K200514
Medtronic
Cardiovascular · 93d
Cleared Dec 13, 2019
EPi-Sense Guided Coagulation System with VisiTrax
K193162
AtriCure, Inc.
Cardiovascular · 28d
Cleared Nov 04, 2019
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
K192125
AtriCure, Inc.
Cardiovascular · 90d
Cleared Oct 01, 2019
Cardioblate CryoFlex Surgical Ablation System
K191526
Medtronic, Inc.
Cardiovascular · 113d
Cleared Jul 24, 2019
Coolrail Linear Pen
K190587
AtriCure, Inc.
Cardiovascular · 139d
Cleared May 30, 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
K190623
Medtronic
Cardiovascular · 80d
Cleared Feb 25, 2019
COBRA Fusion Ablation System
K190151
AtriCure, Inc.
Cardiovascular · 26d
Cleared Dec 19, 2018
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
K182610
Medtronic
Cardiovascular · 89d
Cleared Dec 04, 2018
Coolrail Linear Pen
K183065
AtriCure, Inc.
Cardiovascular · 29d
Cleared Jan 03, 2017
Isolator Multifunctional Linear Pen
K163408
AtriCure, Inc.
Cardiovascular · 29d
Cleared Oct 28, 2014
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K142084
Ncontact Surgical, Inc.
Cardiovascular · 89d
Cleared Apr 05, 2013
ISOLATOR LINEAR PEN
K130521
AtriCure, Inc.
Cardiovascular · 36d
Cleared Apr 01, 2013
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
K123733
Medtronic, Inc.
Cardiovascular · 117d
Cleared Nov 13, 2012
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K120857
Ncontact Surgical, Inc.
Cardiovascular · 237d
Cleared Nov 02, 2012
CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
K121878
Medtronic, Inc.
Cardiovascular · 127d
Cleared Sep 26, 2012
COOLRAIL LINEAR PEN MODEL MCRI
K122611
AtriCure, Inc.
Cardiovascular · 30d
Cleared Jul 13, 2012
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jun 14, 2012
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
K121451
Medtronic, Inc.
Cardiovascular · 29d

About Product Code OCL - Regulatory Context

510(k) Submission Activity

54 total 510(k) submissions under product code OCL since 1997, with 54 receiving FDA clearance (average review time: 105 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - OCL Product Code

Recent submissions under OCL have taken an average of 23 days to reach a decision - down from 107 days historically, suggesting improved FDA processing for this classification.

OCL devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →