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 Ncontact Surgical, Inc..