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FDA 510(k)

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device

K-Number: K190623 · 2019-05-30

ApplicantMedtronic
Decision Date2019-05-30
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2019-05-30 under approval number K190623. 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 Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is a medical device that received FDA 510(k) clearance on 2019-05-30. It is manufactured by Medtronic. The 510(k) number is K190623.

When was Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device approved by the FDA?

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device received FDA 510(k) clearance on 2019-05-30, under approval number K190623.

What company makes Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is manufactured by Medtronic.

What is the FDA product code for Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

The FDA product code for Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is OCL.

Related Clinical Trials

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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)

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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.

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