Search Results
Found 1 results
510(k) Data Aggregation
K Number
K110754Device Name
CRYOPEN CRYOSURGICAL SYSTEM, K102214
Manufacturer
CRYOPEN, INC.
Date Cleared
2011-09-09
(175 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CRYOPEN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cryosurgical unit used for ablative type surgical technique on multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.
Cryosurgical instrument used to necrose unwanted tissue in the gynecological and dermatological practice
Device Description
The CryoPen system provides a safe means of freezing tissue without the use of cryogenic liquids or greenhouse gases. The system consists of multiple pen cores, a Stirling cooler which rejects heat, and a variety of reusable tips for dermatologic and gynecology applications. When used properly, the system will deliver effective temperature for tissue ablation. The model number of this Cryosurgical system is CT-2000.
The Stirling cooler is used to lower the temperature of the CryoPen units to temperatures of -105 degrees Celsius. It operates on a 24 V DC external power supply powered by 115 (or 220) V AC obtained from conventional convenience outlets. The housing of the cooler provides necessary electrical safety features and electromagnetic compatibility. A temperature indicator indicates the readiness of the CryoPen units during cool down,
Ask a Question
Page 1 of 1