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510(k) Data Aggregation

    K Number
    K062337
    Device Name
    MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    2006-10-05

    (56 days)

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

    AARON MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures
    Device Description
    Laparoscopic electrodes and handles are surgical instruments with interchangeable tip inserts designed to be introduced through a 5.5mm diameter (or larger) cannula, during laparoscopic surgical procedures. The devices can be used with electrosurgical generators. The interchange ability of the tip inserts allows for three main benefits: - . A removable insert allows for easier cleaning and disinfection of the instrument components. - Versatility of the instrument is greatly increased as one handle can accept many tip configurations, - Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged. The device consists of two components: an insulated, reusable handle and a series of reusable tips. Radiofrequency energy is passed to the tip through the handle and shaft by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.
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    K Number
    K061307
    Device Name
    BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    2006-07-18

    (69 days)

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

    AARON MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bovie Suture Remover is used to perform suture removal procedures in health care facilities and veterinary offices. The suture removal procedures in which the sutures are located externally on the surface of the skin.
    Device Description
    The Suture Remover consists of a rechargeable power handle, charging stand, and a sterile, single-use kit distributed in a multipack. The single-use kit includes three components, two of which are Class I devices (forceps and gauze) commonly used in predicate suture removal kits. The forceps and gauze components are substantially equivalent to those included in other Class I, Premarket notification-exempt devices. The single-use tip component is included in the sterile kit. After the handle is charged, the tip is attached to the power handle. The bottom of the tip is placed flat against the sutured skin surface so that the tip filament only touches the suture. The button is pressed, delivering heat to the filament for about 0.5 second prior to deactivating. This process is completed for all sutures, after which the suture threads are easily removed using the supplied forceps. Using a heated filament to cut the suture provides an advantage over the use of scissors to cut the suture because pulling of the suture prior to the cut is minimized.
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    K Number
    K060117
    Device Name
    BOVIE BUTTON REMOTE HAND SWITCH
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    2006-02-22

    (36 days)

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

    AARON MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boyie Button Remote Hand Switch is intended for use to remotely activate the CUT and COAOULATION model of an election Technological generator to deliver monopolar Radiofrequency current. The switch also serves as the connection between the electrosurgical accessory and the generator.
    Device Description
    The Bovie Remote Hand Switch is a sterile, single-use electrosurgical accessory that is used to activate the CUT and COAGULATION modes of an electrosurgical generator, which operates an attached monopolar accessory. The switch also serves as the connection between a monopolar electrosurgical accessory and the generator. The Bovie Remote Hand Switch provides an alternative to the use of footswitch control to deliver RF energy to an attached monopolar accessory.
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    K Number
    K022856
    Device Name
    BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    2003-02-10

    (167 days)

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

    AARON MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bovie IDS 300 High Frequency Electrosurgical Generator is a non-sterile reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.
    Device Description
    The IDS 300 High Frequency Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator for use in the operating arena which features both monopolar and bipolar functions which meet surgical demands for safety, flexibility, and convenience. Functions which the IDS 300 performs includes: monopolar cut; monopolar cut with hemostasis (blend); force coagulation; fulguration; and bipolar.
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    K Number
    K021817
    Device Name
    AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    2002-07-11

    (38 days)

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

    AARON MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aaron 950 High Frequency Electrosurgical Generator models are intended to be used for all electrosurgical cut, blend, coagulation, fulguration, and bipolar procedures.
    Device Description
    The Aaron 950 High Frequency Electrosurgical Generator is a non-sterile, reusable electrosurgical generator, which is designed to generate high frequencies (RF) of high voltage and low amperage current.
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    K Number
    K020579
    Device Name
    AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    2002-05-13

    (81 days)

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

    AARON MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aaron Arthroscopy Electrodes are sterile, single-use electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during arthroscopic surgical procedures.
    Device Description
    Aaron Arthroscopy Electrodes sterile, single-use electrodes that are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during arthroscopic surgical procedures.
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    K Number
    K014201
    Device Name
    AARON REUSABLE ELECTROSURGICAL ELECTRODE
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    2002-02-25

    (66 days)

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

    AARON MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.
    Device Description
    Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.
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    K Number
    K001955
    Device Name
    AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    2000-12-22

    (178 days)

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

    AARON MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001382
    Device Name
    AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    2000-06-27

    (56 days)

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

    AARON MEDICAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000961
    Device Name
    AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    2000-04-19

    (26 days)

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

    AARON MEDICAL INDUSTRIES

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

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