Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880

FDA 510(k)

Class II (US FDA 510(k))

510(k) K013392

Identifiers

510(k) Number: K013392 FDA 510(k)
FDA Product Code: OCL FDA 510(k)
Models / Variants: Cardioblate Surgical Ablation Pen, Model 60811c FDA 510(k)
Cardioblate Surgical Ablation Generator, Model 60880 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4400 FDA 510(k)
Regulation Number: 878.4400 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

This device is a surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue. It consists of a surgical ablation pen (Model 60811c) and a surgical ablation generator (Model 60880) designed for use in cardiac surgery to ablate cardiac tissue using radiofrequency energy.

The device is supplied as a system comprising the pen and generator, intended for use in surgical settings. It received FDA 510(k) clearance under K013392 and is classified as a Class II device under regulation number 878.4400. The product code is OCL, and the device is manufactured by Medtronic Vascular.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cardioblate™ surgical ablation pen - Medtronic, Surgical Ablation Pen - Overview - Cardioblate | Medtronic, Cardioblate Surgical Ablation Pen, Model 60811c; Cardioblate Surgical ..., Cardioblate Surgical Ablation Pen, Model 60811c; Cardioblate Surgical ..., 510(k) Premarket Notification

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K013392	Class II	Active

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Manufacturer

Manufacturer: Medtronic Vascular

Sources (1)

FDA 510(k) K013392 24 fields · synced Oct 6, 2026