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510(k) Data Aggregation

    K Number
    K003050
    Device Name
    CRYOSURGICAL UNIT AND ACCESSORIES
    Manufacturer
    CRYOGEN, INC.
    Date Cleared
    2000-12-26

    (85 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why 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
    K974320
    Device Name
    CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
    Manufacturer
    CRYOGEN, INC.
    Date Cleared
    1998-02-03

    (78 days)

    Product Code
    OCL
    Regulation Number
    878.4400
    Why 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
    K972662
    Device Name
    CRYOGEN CRYOSURGICAL SYSTEM
    Manufacturer
    CRYOGEN, INC.
    Date Cleared
    1997-10-01

    (90 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why 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
    K964971
    Device Name
    CRYOGEN CRYOSURGICAL SYSTEM
    Manufacturer
    CRYOGEN, INC.
    Date Cleared
    1997-03-28

    (106 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why 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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