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510(k) Data Aggregation
K Number
K981724Device Name
O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100
Manufacturer
MEDTREX, INC.
Date Cleared
1998-06-22
(38 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDTREX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The O. R. Pro 300™ Electrosurgical Generator is a general purpose solid state generator used to supply the RF signals to electrosurgical handpieces used on soft tissues where a wide range of tissue types, patient conditions and load impedances are encountered.
Device Description
The OR Pro 300™ is a full powered electrosurgical generator with separate monopolar and bipolar sections. The monopolar section is designed for cutting and coagulation outputs, is intended for use with a patient return electrode, and is a floating, isolated output. The bipolar section incorporates a separate output from the monopolar output and has independently controlled power. The Bipolar section is a floating isolated output and is intended to be used with bipolar instruments. AC power mains is applied to the generator from a detachable line cord. This power mains voltage is converted to a DC voltage and applied to a single RF amplifier. An RF amplifier utilizes power MOSFETs to convert the DC voltage into a RF energy that is suitable for electrosurgical procedures. The generator is activated by either handswitching or footswitching active accessories. Three different types of CUTTING, Pure, Blend 1 and Blend 2, can be selected by the push buttons on the front panel. Two different types of COAG, Pinpoint and Spray, can also be selected on the front panel. In addition, BIPOLAR COAG is provided through the bipolar output jacks.
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K Number
K970130Device Name
HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING
Manufacturer
MEDTREX, INC.
Date Cleared
1997-03-28
(72 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDTREX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970039Device Name
ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)
Manufacturer
MEDTREX, INC.
Date Cleared
1997-02-26
(51 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDTREX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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