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