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510(k) Data Aggregation
K Number
K003050Device Name
CRYOSURGICAL UNIT AND ACCESSORIES
Manufacturer
CRYOGEN, INC.
Date Cleared
2000-12-26
(85 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CRYOGEN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K974320Device Name
CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
Manufacturer
CRYOGEN, INC.
Date Cleared
1998-02-03
(78 days)
Product Code
OCL
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CRYOGEN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CryoGen Cardiac Cryosurgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The cardiac cryoprobes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response, or cryonecrosis.
Device Description
The CryoGen Cardiac Cryosurgery System consists of three components: the Console, which contains the compressors and the dewar. The CryoGen Cardiac Cryosurgery System is a cryosurgical unit incorporating a gas cooled cryoprobe. Operation of the cryosurgical System is based on the Joule-Thomson principle in which pressurized coolants are expanded through a small orifice to produce cooling. The device is intended to produce extreme cold. Temperatures of -100 to -120 °C are developed at the tip of the cryoprobe.
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K Number
K972662Device Name
CRYOGEN CRYOSURGICAL SYSTEM
Manufacturer
CRYOGEN, INC.
Date Cleared
1997-10-01
(90 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CRYOGEN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CryoGen Cryosurgical System is intended for use in the surgical ablation of tissue by the application of extreme cold in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.
Device Description
The CryoGen Cryosurgery System consists of three components: the disposable Control Unit, the Cryoprobe and the Console, which contains the compressor system, microprocessor and user interface. The CryoGen Cryosurgery System is a cryosurgical device incorporating a gas cooled cryoprobe. Operation of the System is based on the Joule-Thomson principle in which pressurized coolants are expanded through a small orifice to produce cooling. The device is intended to destroy tissue by the application of extreme cold. Temperatures of -100 to -120 ℃ are developed at the tip of the cryoprobe. These temperatures are within the range of the predicate devices and is sufficient to achieve the desired tissue effect. None of the coolant comes into contact with the patient or physician. In addition, none of the coolant gases are exhausted into the atmosphere, the system is closed. There is no coeling along the shaft of the probe nor at the handle that is held by the user during treatment.
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K Number
K964971Device Name
CRYOGEN CRYOSURGICAL SYSTEM
Manufacturer
CRYOGEN, INC.
Date Cleared
1997-03-28
(106 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CRYOGEN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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