Cleared Special

Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device

K223508 · Medtronic, Inc. · Cardiovascular

Dec 2022

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K223508 is an FDA 510(k) clearance for the Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device, a Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (Class II — Special Controls, product code OCL), submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 22, 2022, 30 days after receiving the submission on November 22, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K223508 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2022
Decision Date	December 22, 2022
Days to Decision	30 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OCL — Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue