Mc-4000 Console & Probes
by Cryomedics, Inc. 510(k)
Active
510(k) K842959
Overview
The MC-4000 Console and Probes is a cryosurgical device designed for controlled freezing of tissue using cryotherapy. It operates by delivering precise cryogenic temperatures via attached probes, enabling targeted destruction of abnormal tissue such as tumors, warts, or other lesions through rapid freezing and thawing cycles. This device is classified as a cryosurgical unit with associated accessories for medical procedures in general and plastic surgery.
The MC-4000 Console and Probes are supplied as a reusable console system paired with single-use or reusable probes, depending on the specific model referenced. The device is intended for use in clinical settings, including operating rooms and outpatient surgical facilities, and is regulated under FDA 510(k) clearance (K842959) as a Class II medical device. Sterility and maintenance protocols must adhere to manufacturer guidelines to ensure safe and effective operation. Various probe sizes and configurations are available, as indicated by the associated FEI numbers.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842959 | Date7 Dec 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEH
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4350
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Cryomedics, Inc.
Questions
What is the MC-4000 Console & Probes used for?
The MC-4000 Console & Probes is a cryosurgical device designed for controlled freezing of abnormal tissue, such as tumors, warts, or lesions. It achieves this through rapid freezing and thawing cycles using attached probes, making it suitable for procedures in general and plastic surgery. The precise temperature control allows for targeted destruction of tissue while minimizing damage to surrounding healthy areas.
How are the MC-4000 Console and probes supplied?
The MC-4000 Console is supplied as a reusable system, while the probes come in either single-use or reusable configurations depending on the specific model referenced by its FEI number. This flexibility allows clinicians to choose between disposable probes for hygiene or reusable probes for cost efficiency, depending on their clinical workflow and sterilization protocols.
Are the probes for the MC-4000 Console sterile?
Sterility of the probes depends on their type—single-use probes are pre-sterilized and intended for one-time use, while reusable probes must undergo manufacturer-approved sterilization procedures between uses. Always follow Cryomedics’ guidelines for sterilization and maintenance to ensure safe and effective operation.
What probe sizes and configurations are available?
The MC-4000 Console supports multiple probe sizes and configurations, each identified by a unique FEI number (e.g., 3002987034, 3010242262). These variations allow clinicians to select the appropriate probe for different tissue types, lesion sizes, or surgical approaches. Refer to the manufacturer’s documentation for compatibility with your specific console model.
How should the MC-4000 Console be stored?
The MC-4000 Console should be stored in a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. Follow Cryomedics’ maintenance guidelines, including regular calibration checks and cleaning protocols, to ensure optimal performance and longevity. Reusable probes must be stored according to sterilization requirements when not in use.