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 and Medtronic Vascular.
54
Total
54
Cleared
105d
Avg days
1997
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg
133d
recently vs 104d historically
FDA 510(k) Cleared Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue Devices (Product Code OCL)
54 devices
Cleared
Jul 24, 2025
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
AtriCure, Inc.
Cardiovascular
23d
Cleared
Aug 27, 2024
Isolator Synergy EnCapture Ablation System (EMH)
AtriCure, Inc.
Cardiovascular
242d
Cleared
Dec 30, 2022
Isolator® Linear Pen (MLP1)
AtriCure, Inc.
Cardiovascular
233d
Cleared
Dec 22, 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
Medtronic, Inc.
Cardiovascular
30d
Cleared
Jul 26, 2021
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
AtriCure, Inc.
Cardiovascular
157d
Cleared
May 28, 2021
AtriCure Isolator® Synergy™ Surgical Ablation System
AtriCure, Inc.
Cardiovascular
28d
Cleared
Jun 03, 2020
Cardioblate Gemini-s Surgical Ablation Device
Medtronic
Cardiovascular
93d
Cleared
Dec 13, 2019
EPi-Sense Guided Coagulation System with VisiTrax
AtriCure, Inc.
Cardiovascular
28d
Cleared
Nov 04, 2019
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
AtriCure, Inc.
Cardiovascular
90d
Cleared
Oct 01, 2019
Cardioblate CryoFlex Surgical Ablation System
Medtronic, Inc.
Cardiovascular
113d
Cleared
Jul 24, 2019
Coolrail Linear Pen
AtriCure, Inc.
Cardiovascular
139d
Cleared
May 30, 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
Medtronic
Cardiovascular
80d
Cleared
Feb 25, 2019
COBRA Fusion Ablation System
AtriCure, Inc.
Cardiovascular
26d
Cleared
Dec 19, 2018
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
Medtronic
Cardiovascular
89d
Cleared
Dec 04, 2018
Coolrail Linear Pen
AtriCure, Inc.
Cardiovascular
29d
Cleared
Jun 18, 2007
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
Medtronic Vascular
Cardiovascular
139d
Cleared
Jan 25, 2002
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C
Medtronic Vascular
Cardiovascular
102d
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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - OCL Product Code
Recent submissions under OCL have taken an average of 133 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.
OCL devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →