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510(k) Data Aggregation
K Number
K131058Device Name
BIPOLAR FORCEPS
Manufacturer
Date Cleared
2013-10-25
(192 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
BOSTON ENDO-SURGICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Tissue grasping and control of bleeding of small vessels by bipolar coagulation.
Device Description
The Bipolar Forceps device is a single use hand held insulated medical device approximately 295mm in overall length featuring a 190mm distance from the user's grasp to the tip. The bayonet offset is 1.5cm. The tips are Titanium Nitride coated and have polished contact surfaces 1.5mm wide by 1cm long. The device is offered in straight and 20 degree angled tips. The Bipolar Forceps are sold as a single use sterile packaged device used in general surgical procedures. The Bipolar Forceps are limited to maximum 70 watts and shall be used only by personnel with training in electrosurgical procedures and with compatible generators compliant with IEC 60601 requirements. The Bipolar Forceps are rated at 1000V peak and can be used with a compatible reusable pin plug cable (1.8mm pin, 5.8mm spacing). The Bipolar Forceps are single use disposable devices packaged in double blisters with Tyvek lid.
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