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510(k) Data Aggregation

    K Number
    K000245
    Device Name
    CSM STRETTA SYSTEM
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    2000-04-18

    (82 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONWAY STUART MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000170
    Device Name
    SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    2000-02-14

    (27 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONWAY STUART MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992542
    Device Name
    TUBULAR ELECTRODE DEVICE
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1999-10-27

    (89 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONWAY STUART MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for coagulation of tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
    Device Description
    Model A 4000 Tubular Electrode, 4 Needle, No Irrigation or Aspiration Model A 4000 Tubular Electrode, 4 Needle, With Irrigation or Aspiration Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), No Irrigation or Aspiration Model A 4400 Tubular Electrode, 8 Needle (2 rows of 4), With Irrigation or Aspiration Model A 8000 Tubular Electrode, 8 Needle, No Irrigation or Aspiration Model A 8000 Tubular Electrode, 8 Needle, With Irrigation or Aspiration
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    K Number
    K991529
    Device Name
    CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1999-09-14

    (134 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONWAY STUART MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stretta Control Module Model S400 RF electrosurgical generator with pump, in combination with CSM electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.
    Device Description
    The Stretta Control Module Model S400 is an electrosurgical generator that is designed to deliver controlled low level radiofrequency energy for localized tissue coagulation. The Stretta generator has controls for maximum temperature, power delivered, energy delivered and time of energy delivered. The unit has readout for total energy delivered, impedance, maximum power and temperature for up to six channels. Connectors located on the front panel include electrode connectors and a foot pedal. A fluid pump is integrated into the Stretta generator to deliver cooling fluid to the surrounding tissue adjacent to the electrode. System accessories include an AC power cord, a single-pedal footswitch and a connecting cable.
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    K Number
    K990724
    Device Name
    CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1999-08-13

    (161 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONWAY STUART MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conway Stuart Medical Model 100 Irrigation Pump and Accessories is indicated for irrigation of tissue.
    Device Description
    Model 100 Irrigation Pump and Accessories
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    K Number
    K991291
    Device Name
    STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1999-07-14

    (90 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONWAY STUART MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for coagulation of tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
    Device Description
    Conway Stuart Medical Model C8 Needle Inflatable Basket Catheter Electrode with Aspiration
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    K Number
    K983986
    Device Name
    CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1999-03-23

    (134 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONWAY STUART MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conway-Stuart Medical Model C4 RF Generator, in combination with Conway Stuart Medical electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.
    Device Description
    Model C4 Radiofrequency Electrosurgical Generator
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    K Number
    K983116
    Device Name
    ELECTROSURGICAL INFLATABLE BASKET ELECTRODES
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1998-12-03

    (90 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONWAY STUART MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for coagulation of tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
    Device Description
    Not Found
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    K Number
    K983415
    Device Name
    DELIVERY SHEATH
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1998-12-01

    (63 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONWAY STUART MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used with an endoscope or other medical instrument when repeated insertion and removal of the instrument is anticipated.
    Device Description
    Not Found
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    K Number
    K981589
    Device Name
    ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1998-07-30

    (87 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONWAY STUART MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for coagulation of tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
    Device Description
    Electrosurgical Basket Electrodes
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