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510(k) Data Aggregation

    K Number
    K992901
    Device Name
    GYNECARE VERSAPOINT G-VAP ELECTRODE
    Manufacturer
    GYNECARE, INC.
    Date Cleared
    2000-01-18

    (141 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNECARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation. Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa Endometrial ablation
    Device Description
    The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.
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    K Number
    K982738
    Device Name
    VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
    Manufacturer
    GYNECARE, INC.
    Date Cleared
    1999-03-01

    (207 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNECARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa. Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa
    Device Description
    The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.
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    K Number
    K962482
    Device Name
    SCUBA SYSTEM
    Manufacturer
    GYNECARE, INC.
    Date Cleared
    1996-11-01

    (128 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNECARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scuba is intended to be used for tissue cutting, vaporization and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.
    Device Description
    The Scuba is a bipolar electrosurgical system designed for hysteroscopic surgical correction of myomas, polyps, intrauterine adhesions, and septate uteri. It consists of an electrosurgical generator, a footswitch, three types of electrodes, and a cable connecting the electrode to the generator. The generator is designed to operate from any voltage source between 95-125V and 190-250V a.c. at 50 or 60Hz. It provides six modes of operation (i.e., six waveforms): three vaporize modes, two blend modes (a combination of vaporization and coagulation) and a desiccate mode similar to the traditional coagulation waveform. The generator controls the power settings from 1 to 200 Watts. A green fluorescent display provides up to 16 characters of alphanumeric information, including the selected mode of operation, the power settings, and other messages related to the operation of the generator. Like other electrosurgical equipment, the generator is designed to be located outside the sterile field, with adjustment of operating settings performed by ancillary operating staff. Three electrode configurations are available: the Spring, Ball and Twizzle. The electrodes are identical in construction except for the distal end and are designed for insertion down a 5 French or larger working channel of commercially available hysteroscopes. The electrodes are operated in a conductive (i.e., saline) fluid environment. When connected to the generator via the connector cable, the system detects the type of electrode attached and automatically adjusts the default power settings to the optimal level for each electrode type. The surgeon can change the default power settings as required. The electrodes are provided as sterile, single-use items. The connector cable is steam sterilizable, designed for twenty times reuse.
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