Atricure Cryo Module System - Atricure Cryo Module System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142203 FDA 510(k)
- FDA Product Code
- GXH FDA 510(k)
- Models / Variants
- Atricure Cryo Module System FDA 510(k)EUDAMED
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 cryoICE cryoablation probe is a cryogenic surgical device designed for controlled tissue ablation through extreme cold. It falls under the category of surgical cryogenic instruments, delivering precise cryoenergy to target tissues while minimizing collateral damage. The system integrates with the Atricure Cryo Module to enable safe and effective cryoablation procedures, leveraging thermal capacity and active defrost mechanisms for enhanced performance and patient safety.
This device is supplied as a reusable system with single-use cryoablation probes, intended for use in neurosurgical and pain management procedures under direct visualization. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The cryoICE probe features a retractable, malleable design with a flexible tube set for improved maneuverability in tight anatomical spaces. Sterilization and storage requirements are manufacturer-specified, ensuring compliance with surgical standards.
Frequently asked questions
What types of medical procedures is the cryoICE cryoablation probe primarily used for, and why is its design advantageous in those settings?
The cryoICE cryoablation probe is primarily used in neurosurgical and pain management procedures under direct visualization. Its retractable, malleable design and flexible tube set allow for improved maneuverability in tight anatomical spaces, making it well-suited for delicate or confined areas where precision is critical.
Is the cryoICE cryoablation probe single-use or reusable, and what does this mean for my facility’s workflow?
The cryoICE cryoablation probe is designed as a single-use component, while the Atricure Cryo Module itself is reusable. This means each probe can be used once per patient, reducing cross-contamination risks, while the module can be sterilized and reused across multiple procedures, streamlining workflow and cost efficiency.
How should the cryoICE cryoablation probe be stored, and are there any specific sterility or handling requirements?
The cryoICE cryoablation probe must be stored according to the manufacturer’s specifications to maintain sterility and functionality. Since it is single-use, it should be kept in its original packaging until immediately before use, and any storage conditions (e.g., temperature, humidity) should align with the manufacturer’s guidelines to preserve its performance for cryoablation.
What regulatory pathways has the cryoICE cryoablation probe followed, and what does this mean for compliance in my facility?
The cryoICE cryoablation probe has received FDA 510(k) clearance and MDR authorization, indicating it has been evaluated for safety and effectiveness under applicable regulations. This means your facility can rely on its compliance with U.S. and EU standards, though you should verify the specific regulatory requirements for your region and ensure proper documentation is maintained.
Does the cryoICE cryoablation probe come in different sizes or models, and how might this affect procedure selection?
The device data does not specify exact sizes or models, but the probe’s retractable and malleable design suggests flexibility for various anatomical needs. While the exact variations aren’t detailed, the system’s adaptability likely accommodates different procedural requirements in neurosurgery and pain management, allowing clinicians to choose based on their specific case demands.
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: cryoICE Cryoablation Probes | Ablation Therapy - AtriCure, Inc., PDF U.S. Indications: Cryoablation System - AtriCure, Inc., cryoICE Cryoablation Probes | Cryosurgical Treatment | AtriCure
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K142203 | Class II | Active |
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Manufacturer
- Manufacturer
- Atricure, Inc.
Sources (2)
- FDA 510(k) K142203 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026