510(k) K192125

Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen by AtriCure, Inc. — Product Code OCL

K192125 is an FDA 510(k) premarket notification submitted by AtriCure, Inc. for the device "Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen". The FDA issued a decision of Substantially Equivalent on November 4, 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. AtriCure, Inc. has at least 10 other 510(k) clearances on record.