Identifiers
- 510(k) Number
- K243157 FDA 510(k)
- FDA Product Code
- GXH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4250 FDA 510(k)
- Regulation Number
- 882.4250 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AtriCure cryoICE BOX (ACM) is a cryogenic device designed for surgical applications. It is classified as a Class II medical device under FDA regulations.
The device is supplied sterile and intended for single-use. It is MRI safe and available in specific sizes. Storage instructions should follow the manufacturer's guidelines.
Frequently asked questions
What is the AtriCure cryoICE BOX (ACM) used for?
The AtriCure cryoICE BOX (ACM) is a cryogenic device designed for surgical applications. It is intended for use in medical procedures that require cryogenic cooling.
Is the cryoICE BOX (ACM) sterile and single-use?
Yes, the device is supplied sterile and is intended for single-use. This ensures that each procedure uses a fresh, uncontaminated device.
Is the cryoICE BOX (ACM) safe to use in an MRI environment?
Yes, the AtriCure cryoICE BOX (ACM) is MRI safe, making it suitable for use in environments where magnetic resonance imaging is present.
How should the cryoICE BOX (ACM) be stored?
Storage instructions for the cryoICE BOX (ACM) should be followed according to the manufacturer's guidelines to ensure the device remains in optimal condition.
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 | K243157 | Class II | Active |
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Manufacturer
- Manufacturer
- Atricure, Inc.
Sources (1)
- FDA 510(k) K243157 24 fields · synced Sep 21, 2026