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510(k) Data Aggregation
K Number
K140422Device Name
HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM
Manufacturer
HET SYSTEMS, LLC
Date Cleared
2014-06-05
(107 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
HET SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HET™ Bipolar Electrocautery Forceps and Monitor is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The HET™ Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.
Device Description
The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cable to the bipolar output of an electrosurgical generator.
The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Systems HET™ Bipolar Electrocautery Forceps and Monitor may be used with any Bipolar Electrosurgical generator in the coagulation mode with an output power set at 10 W and a maximum voltage of 1250v.
The monitor displays the temperature at the forceps-tissue interface. The HET" Monitor does not generate RF energy.
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K Number
K121085Device Name
HET BIPOLAR LIGATOR SYSTEM
Manufacturer
HET SYSTEMS, LLC
Date Cleared
2012-11-20
(224 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
HET SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HET™ Bipolar Electrocautery Forceps and Monitor are intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The HET™ Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.
The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Bipolar Electrocautery Forceps and Monitor may be used with the CONMED HYFRECATOR® 2000 or VALLEYLAB SURGISTAT II RF energy generators.
Device Description
The HET™ Bipolar Electrocautery System is comprised of the HET™ Bipolar Forceps and the HET™ Monitor.
The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cable to the bipolar output of an electrosurgical generator.
When connected to the HET™ Monitor, the HET™ Bipolar Forceps has an integrated tissue illumination feature and a temperature probe. The HET™ Monitor is an accessory that can be used only with the HET™ Bipolar Forceps when used in conjunction with the CONMED HYFRECATOR® 2000 or the VALLEYLAB SURGISTAT II RF generators. The monitor displays the temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.
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K Number
K110143Device Name
HET BIPOLAR ELECTROCAUTERY FORCEPS
Manufacturer
HET SYSTEMS, LLC
Date Cleared
2011-06-02
(135 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
HET SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HET™ Bipolar Electrocautery Forceps is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The accessory monitor provides power for a timer, a temperature sensor and an LED light source mounted on the disposable forceps.
Device Description
The HET™ Electrocautery System is comprised of the HET™ Bipolar Electrocautery Forceps and the HET™ Monitor.
The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cabel to the bipolar output of an electrosurqical generator. The HET™ Bipolar Forceps has an integrated illumination and a temperature probe. The HET™ Bipolar Forceps can be connected and used with any commercial bi-polar RF generator which is rated less than 50W.
The HET™ Monitor is an optional accessory that can be used only with the HET™ Bipolar Forceps when used in conjunction with the CONMED HYFRECATOR® 2000 or the VALLEYLAB SURGISTAT II RF generators. The monitor displays the time (in seconds) of RF energy delivery and the temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.
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