Cryosurgical Unit and Accessories
by Cryogen, Inc. 510(k)
Active
510(k) K003050
Overview
This device is a Cryosurgical Unit and Accessories designed for controlled freezing of tissue using cryogenic temperatures. It falls under the category of surgical instruments used in procedures such as skin lesion removal, tumor ablation, and other dermatological or plastic surgery applications, leveraging liquid nitrogen or similar cryogens for precise tissue destruction.
The system is supplied as a complete unit with associated accessories and is intended for single-use or reusable components, depending on the specific parts. It is regulated under FDA 510(k) clearance (K003050) and is intended for use in clinical settings by trained professionals. No specific sterility or MRI safety information is provided in the data, and storage requirements are not detailed beyond standard cryogenic handling protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESU | NumberK003050 | Date26 Dec 2000 | 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- Withdrawn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
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESU
Other devices from Cryogen, Inc.
Questions
What types of medical procedures is this cryosurgical unit primarily used for?
This cryosurgical unit is designed for controlled freezing of tissue using cryogenic temperatures, making it suitable for procedures like skin lesion removal and tumor ablation. It is commonly used in dermatological and plastic surgery applications where precise tissue destruction is required.
Is this device intended for single-use or reusable components, and how should I determine which parts are which?
The device includes both single-use and reusable components, depending on the specific accessory. The manufacturer, Cryogen, Inc., categorizes parts this way, so you should refer to their instructions or documentation to identify which accessories are intended for single-use and which can be reused after proper cleaning and sterilization.
What is the regulatory pathway for this cryosurgical unit, and how does it relate to its intended use?
This device has received FDA clearance through a 510(k) submission (K003050) under the General, Plastic Surgery advisory committee category. The clearance indicates it is intended for use in clinical settings by trained professionals, specifically for controlled freezing of tissue in procedures like lesion removal or tumor ablation.
Does this unit require any special storage conditions beyond standard cryogenic handling?
The provided data does not specify any unique storage requirements beyond general cryogenic handling protocols. Since the device uses liquid nitrogen or similar cryogens, it should be stored in accordance with standard practices for cryogenic fluids to ensure safety and functionality.