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510(k) Data Aggregation
K Number
K012214Device Name
CRYOPEN AND ACCESSORIES
Manufacturer
Date Cleared
2002-04-26
(284 days)
Product Code
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CIMEX BIOTECH, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended Use: Cryosurgical unit used for ablative type surgical technique
Indications for use: Multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.
Device Description
The CryoPen system provides a means of freezing tissue without the use of cryogenic liquids or gases. The system consists of three hand-held freezing modules, a refrigeration unit, and disposable tips. When used properly, the system will deliver effective temperature for tissue ablation. The refrigeration component is the largest unit, and is used to lower the temperature of the CryoPen units to temperature of -100 C. It operates on 115 VAC obtained from conventional convenience outlets. The supporting housed in the refrigerator cabinet include a DC power source to indicate the temperature of the CryoPen units during cool down, and all other necessary control and electrical safety features. There are currently three different sizes of the hand-held modules: a 0.4 inch diameter unit, a 0.25 inch diameter unit, and a 0.19 inch diameter unit.
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