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510(k) Data Aggregation
K Number
K102372Device 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
878.4400Why 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
K092634Device 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
878.4400Why 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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