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510(k) Data Aggregation

    K Number
    K102372
    Device Name
    OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB
    Manufacturer
    JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO
    Date Cleared
    2010-11-03

    (75 days)

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

    JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OBS Disposable Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System(CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS(i.e.REM,ARM,NESSY etc.).
    Device Description
    OBS Disposable Electrosurgical Pads are disposable, non-sterile dispersive electrode with or without a pre-attached cord and available in a comprehensive range of shapes and sizes(adult and pediatric). OBS disposable electrosurgical pads, Solid (Model:GBS-Dm) are for use with generators that do not have a Contact Quality Monitoring System(CQMS).OBS disposable electrosurgical pads, Split (Model:GBS-Db) are for use with generators that have a Contact Quality Monitoring System(i.e. REM,ARM,NESSY etc.).
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    K Number
    K092634
    Device Name
    OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF
    Manufacturer
    JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO
    Date Cleared
    2009-12-01

    (96 days)

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

    JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df are used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with a 510k-clearance ESU generator. The device is disposable and supplied sterile with an electrode tip.
    Device Description
    The OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df are used for the cutting and coagulation of soft tissue and have a connector attached to a 3M conductive cable and are designed for use with 510K-clearance generator. The connector or pluq fits into the mono-polar side of a 510K-clearance generator. The handpieces (OBS-Db or OBS-Dr) are made of plastic with two buttons or a rocker switch toward the distal part of the pencil in the case of the hand-controlled pencils, while the foot-controlled pencils(OBS-Df) that is activated by a monopolar footswitch connected to the generator (the footswitch is an accessory of the generator). One button or switch is to control the CUT mode of the ESU while the other controls the COAG mode.
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