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. and Medtronic, Inc..
List of Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue devices (product code OCL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →