510(k) K190623

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device by Medtronic — Product Code OCL

K190623 is an FDA 510(k) premarket notification submitted by Medtronic for the device "Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device". The FDA issued a decision of Substantially Equivalent on May 30, 2019. The device falls under product code OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue), a Class II device regulated under 21 CFR 878.4400. Medtronic has at least 10 other 510(k) clearances on record.