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FDA 510(k)

Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device

K-Number: K182610 · 2018-12-19

ApplicantMedtronic
Decision Date2018-12-19
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2018-12-19 under approval number K182610. 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 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device?

Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device is a medical device that received FDA 510(k) clearance on 2018-12-19. It is manufactured by Medtronic. The 510(k) number is K182610.

When was Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device approved by the FDA?

Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device received FDA 510(k) clearance on 2018-12-19, under approval number K182610.

What company makes Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device?

Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device is manufactured by Medtronic.

What is the FDA product code for Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device?

The FDA product code for Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device is OCL.

Related Clinical Trials

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) 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)

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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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