Coolrail Linear Pen Model MCRI
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122611 FDA 510(k)
- FDA Product Code
- OCL 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)
The Coolrail Linear Pen Model MCRI is a surgical device designed for cutting, coagulation, and/or ablation of tissue, including cardiac tissue. It is manufactured by AtriCure, Inc. and is classified under product code OCL.
This device is intended for use in general and plastic surgery settings. It is supplied as a single-use device and is not MRI safe. The Coolrail Linear Pen Model MCRI has received FDA 510(k) clearance with decision code SESE and is classified as a Class II device.
Frequently asked questions
What is the Coolrail Linear Pen Model MCRI used for?
The Coolrail Linear Pen Model MCRI is a surgical device designed for cutting, coagulation, and/or ablation of tissue, including cardiac tissue, in general and plastic surgery settings.
Is the Coolrail Linear Pen Model MCRI reusable or single-use?
The Coolrail Linear Pen Model MCRI is supplied as a single-use device and is not MRI safe. It should be discarded after a single procedure to ensure optimal performance and patient safety.
What regulatory status does the Coolrail Linear Pen Model MCRI have?
The Coolrail Linear Pen Model MCRI has received FDA 510(k) clearance with decision code SESE and is classified as a Class II device. It is manufactured by AtriCure, Inc. and is intended for use in general and plastic surgery settings.
What are the specifications of the Coolrail Linear Pen Model MCRI?
The Coolrail Linear Pen Model MCRI is classified under product code OCL and is designed for cutting, coagulation, and/or ablation of tissue. It is a single-use device that has received FDA 510(k) clearance as substantially equivalent to predicate devices.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122611 | Class II | Active |
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Manufacturer
- Manufacturer
- Atricure, Inc.
Sources (1)
- FDA 510(k) K122611 24 fields · synced Sep 21, 2026