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510(k) Data Aggregation
K Number
K201224Device Name
Electrosurgical Generator and Accessories
Manufacturer
Date Cleared
2020-09-18
(135 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Medrange
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Electrosurgical Generator 8070 is indicated for monopolar or bipolar surgery to achieve cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.
Device Description
8070 is an Electrosurgical Generator with Monopolar Pure cut, Monopolar Bland Cut, Bipolar function. 8070 consists of HF generator and accessories. The device generates HF power, which is transmitted to the tissue through the output Pencil. Operator selects the output function and power with the front panel. The indicator is used to indicate the setup status and output status of the output is controlled by foot or hand switch.
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K Number
K122092Device Name
MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM
Manufacturer
Date Cleared
2012-10-23
(99 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDRANGE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EES 100 with Accessories is intended to deliver argon gas for argon plasma coagulation on tissue when used in conjunction with an Electrosurgical Generator and applicators or probes.
Device Description
The EES 100 is an expansion system for the electrosurgical unit (ESU). The EES 100 is not a generator. It is designed for the enhanced control of bleeding and the electrosurgical destruction of tissue in multispecialty procedures in the operating room or endoscopy suite. The EES 100 equipped with the argon module is used in combination with a high-frequency generator and an electrosurgical handpiece and the users can select appropriate operation modes: Pulse, Endo or Ar-cut mode to fulfill various argon surgical requirements.
The device consists of four major assemblies integrated into one system: Main Unit, Universal Cart, the Argon Module, Accessories. The EES 100 provides finer maneuverability and fits a variety of surgical equipments, endoscopes and instruments. The Software is equipped in the device. Dispense with setting or modification for the user. Dispense with training before using the device.
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K Number
K102114Device Name
MEDRANGE ELECTROSURGICAL GENERATOR
Manufacturer
Date Cleared
2010-11-22
(117 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDRANGE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MB8010 Electrosurgical generator is indicated for monopolar cutting and coagulation and bipolar coagulation in surgical procedures and is intended to be used with monopolar handpieces and ground pad or bipolar handpieces and footswitches.
Device Description
Medrange MB 8010 ESU is an electrosurgical generator with monopolar pure cut; blend cut, coagulation and bipolar coagulation functions which meet surgical demands. Those functions are achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show status of self-test and monitoring. The final output power control is made through foot or hand switches. Both monopolar and bipolar electrodes are provided. It is designed to comply with international safety standards.
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