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510(k) Data Aggregation

    K Number
    K050308
    Device Name
    THERMAL CAUTERY PROBE
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2005-02-25

    (17 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Why did this record match?
    Product Code :

    HQR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the simultaneous cutting and cauterization of soft tissue during surgery.
    Device Description
    The Starion Instruments Thermal Cautery Probe is a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Thermal Cautery Probe allows the surgeon to position the probe in the region of tissue to be cauterized. The Thermal Cautery Probe features a handle, a finger/footswitch control and power cord for connection to a Starion Instruments power supply.
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    K Number
    K990064
    Device Name
    DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
    Manufacturer
    OPHTHALMIC TECHNOLOGIES, INC.
    Date Cleared
    1999-04-04

    (86 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Why did this record match?
    Product Code :

    HQR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTI Di-thex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, and for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.
    Device Description
    The system consists of a central control unit that supplies radio frequency energy to a handpiece. The unit can be used for standard diathermy procedures, and can be also used as a cutting instrument for membrane dissection in the eye with the appropriate handpieces and tips. Power level is microprocessor-controlled, and the power-level setting is shown by a bar-graph display on the front panel. The system has a set of alarms which alert the user and suspend operation for such cases as overtemperature, overvoltage, and computer errors.
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    K Number
    K980522
    Device Name
    REFRACTEC MCS-100
    Manufacturer
    REFRACTEC, INC.
    Date Cleared
    1998-07-22

    (162 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Why did this record match?
    Product Code :

    HQR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K972749
    Device Name
    PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
    Manufacturer
    C.M. CHANCE LTD.
    Date Cleared
    1998-03-13

    (233 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Why did this record match?
    Product Code :

    HQR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pao Bipolar Coaxial Coagulator is for cauterizing microscopic vessels on the conjunctiva and sclera. It is for extraocular surgery and it is not to be used for intraocular surgery (within the anterior or posterior segment of the eye).
    Device Description
    Not Found
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    K Number
    K952151
    Device Name
    STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
    Manufacturer
    STORZ
    Date Cleared
    1996-03-04

    (301 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Why did this record match?
    Product Code :

    HQR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Storz Ophthalmic Bipolar Cautery devices are used to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. The D8200 Bipolar Forceps are used during ophthalmic procedures, coagulating extraocular tissue by pinching it between the forcep tips. The D8201 Bipolar Eraser is also used during surgery for cauterization of extraocular vessels, while the D8203 Bipolar Intraocular Eraser is used in posterior ophthalmic surgical procedures to cauterize vessels internal to the eye.
    Device Description
    Storz D8200 series Ophthalmic Bipolar Cautery devices are accessories to Storz DAISY®, Protege®, and PREMIERE® Ophthalmic Microsurgical Systems. The D8200 is a reusable bipolar forceps, D8201 is a reusable bipolar eraser, and the D8203 is a reusable bipolar intraocular eraser. The D8202 bipolar cord is used to connect the three cautery instruments to the Storz DAISY® Microsurgical System; the D8204 bipolar cord is used to connect the three cautery instruments to the Storz Protege® and PREMIERE® Microsurgical Systems. All three instruments and both cords have Lemo™ locking connectors. The D8200 forceps are composed of surgical grade stainless steel; the D8201 and D8203 erasers are composed of surgical grade stainless steel and spring steel, and liguid crystal polymer insulation. These materials raise no questions of biocompatibility.
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    K Number
    K955158
    Device Name
    SURGITRON
    Manufacturer
    ELLMAN INTL., INC.
    Date Cleared
    1996-02-09

    (88 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Why did this record match?
    Product Code :

    HQR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K952569
    Device Name
    GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
    Manufacturer
    GAMP & ASSOC.
    Date Cleared
    1996-01-05

    (214 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Why did this record match?
    Product Code :

    HQR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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