510(k) K223508

Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device by Medtronic, Inc. — Product Code OCL

K223508 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device". The FDA issued a decision of Substantially Equivalent on December 22, 2022. 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, Inc. has at least 10 other 510(k) clearances on record.