CryoPro Maxi and CryoPro Mini
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K982280 FDA 510(k)
- FDA Product Code
- GEH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4350 FDA 510(k)
- Regulation Number
- 878.4350 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CryoPro Maxi and CryoPro Mini are cryosurgical accessories designed for the controlled delivery of liquid nitrogen. Classified as cryosurgical units, they are intended for use in procedures requiring precise freezing of tissue, such as skin lesion treatment and cervical erosions.
These devices are supplied as reusable, non-sterile units with capacities of 500 ml (Maxi) and 350 ml (Mini). They are MRI-unsafe and require proper storage to maintain liquid nitrogen levels. Authorized under FDA 510K and MDR, they are regulated as Class II medical devices under the product code GEH and regulation number 878.4350.
Frequently asked questions
What are the key differences between the CryoPro Maxi and CryoPro Mini in terms of capacity and intended use?
The CryoPro Maxi and CryoPro Mini differ primarily in their liquid nitrogen capacity, with the Maxi holding 500 ml and the Mini holding 350 ml. Both are designed for controlled cryosurgical procedures, such as treating skin lesions and cervical erosions, but the larger capacity of the Maxi may be preferred for longer or more extensive treatments where higher volumes of liquid nitrogen are required.
Are the CryoPro Maxi and Mini reusable or single-use devices, and what does this mean for my workflow?
The CryoPro Maxi and Mini are reusable devices, meaning they are intended for multiple uses after proper cleaning and maintenance. This design allows for cost efficiency over time, though it requires adherence to manufacturer guidelines for sterilization (if applicable) and storage to ensure safe and effective performance between procedures.
How should I store these devices to maintain their functionality, particularly regarding liquid nitrogen levels?
These devices must be stored in a way that preserves their liquid nitrogen levels, as they are not pre-filled with the cryogen. Proper storage involves keeping them in an upright position in a dedicated cryosurgical storage unit or insulated container designed for liquid nitrogen. Avoid exposure to heat or direct sunlight, and ensure the storage area is secure to prevent leaks or spills.
Can these devices be used in an MRI environment, and if not, what precautions should I take?
No, the CryoPro Maxi and Mini are MRI-unsafe. This means they should never be brought into an MRI scanning room or placed near MRI equipment, as the liquid nitrogen and materials could interfere with the magnetic field or pose a safety risk. Always confirm the device’s location and ensure it is stored in a designated non-MRI area.
What regulatory pathways have these devices undergone, and how does this affect their use in clinical settings?
The CryoPro Maxi and Mini are authorized under FDA 510K and MDR (Medical Device Regulation) pathways, confirming they meet regulatory standards for safety and effectiveness as cryosurgical accessories. Their classification as Class II medical devices under product code GEH and regulation number 878.4350 indicates they undergo additional scrutiny beyond general controls, ensuring compliance with strict manufacturing and performance requirements for use in procedures like tissue freezing.
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: CryoPro® for cryosurgery - Cortex Technology, CryoPro Cryosurgery Hand-Held Devices Maxi OR Mini, PDF CryoPro - elmed.ro, CORTEX CRYOPRO INSTRUCTION MANUAL Pdf Download | ManualsLib, CryoPro Cryotherapy Devices by Cortex - Attikouris Medical
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 | K982280 | Class II | Active |
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Manufacturer
- Manufacturer
- Cortex Technology Aps
Sources (2)
- FDA 510(k) K982280 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026