Cardioblate Gemini-s Surgical Ablation Device
K-Number: K200514 · 2020-06-03
ApplicantMedtronic
Decision Date2020-06-03
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Cardioblate Gemini-s Surgical Ablation Device is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2020-06-03 under approval number K200514. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cardioblate Gemini-s Surgical Ablation Device?
Cardioblate Gemini-s Surgical Ablation Device is a medical device that received FDA 510(k) clearance on 2020-06-03. It is manufactured by Medtronic. The 510(k) number is K200514.
When was Cardioblate Gemini-s Surgical Ablation Device approved by the FDA?
Cardioblate Gemini-s Surgical Ablation Device received FDA 510(k) clearance on 2020-06-03, under approval number K200514.
What company makes Cardioblate Gemini-s Surgical Ablation Device?
Cardioblate Gemini-s Surgical Ablation Device is manufactured by Medtronic.
What is the FDA product code for Cardioblate Gemini-s Surgical Ablation Device?
The FDA product code for Cardioblate Gemini-s Surgical Ablation Device is OCL.
Related Clinical Trials
NCT07475091
Standardizing Swallow Pressure Measurements
NOT_YET_RECRUITING
NCT07372677
Pocket-X Gel Non-surgical Periodontal Therapy
RECRUITING
NCT07301385
Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study
ACTIVE_NOT_RECRUITING
NCT06940752
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
ENROLLING_BY_INVITATION
NCT04235764
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
RECRUITING
NCT07607860
Clinical Evaluation of the Adaptilens Accommodating IOL
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 42201559
Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system.
Journal of robotic surgery (2026)
PMID: 41886403
Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023.
Urology practice (2026)
PMID: 41572440
Regulating Medical Devices: The Values and Politics of the US FDA Review Process.
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)
PMID: 40775988
B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation.
Studies in health technology and informatics (2025)
Other Devices by Medtronic
K161249Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
K171253Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
K181132Tri-Ad 2.0 Adams Tricuspid Band
K191851VS3-IR
Related Devices (Code: OCL)
K163408Isolator Multifunctional Linear PenAtriCure, Inc.
K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation DeviceMedtronic
K183065Coolrail Linear PenAtriCure, Inc.
K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.
K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.
K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.