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Found 13 results
510(k) Data Aggregation
K Number
K070871Device Name
STARION UNIVERSAL POWER SUPPLY
Manufacturer
STARION INSTRUMENTS
Date Cleared
2007-04-13
(15 days)
Product Code
HQO
Regulation Number
886.4115Why did this record match?
Applicant Name (Manufacturer) :
STARION INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the simultaneous cutting and cauterization of soft tissue during surgery.
Device Description
The Starion Instruments Universal Power Supply (UPS) is a reusable, AC powered unit intended for use with cautery instruments incorporating Starion technology for the simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Universal Power Supply (UPS) features an on/off switch, green power-on LED indicator, variable output and volume controls/indicators, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and audible tones to indicate activation of the instrument heating element.
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K Number
K062257Device Name
STARION INSTRUMENTS THERMAL LITIGATING SHEARS
Manufacturer
STARION INSTRUMENTS
Date Cleared
2006-10-10
(67 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
STARION INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the simultaneous cutting and cauterization of soft tissue during surgery.
Cutting of natural or synthetic, non-metallic, sutures during surgery.
Device Description
The Starion Instruments Thermal Ligating Shears are a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Thermal Ligating Shears allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a switch, which activates heating element(s) in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.
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K Number
K050308Device Name
THERMAL CAUTERY PROBE
Manufacturer
STARION INSTRUMENTS
Date Cleared
2005-02-25
(17 days)
Product Code
HQR
Regulation Number
886.4100Why did this record match?
Applicant Name (Manufacturer) :
STARION INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the simultaneous cutting and cauterization of soft tissue during surgery.
Device Description
The Starion Instruments Thermal Cautery Probe is a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Thermal Cautery Probe allows the surgeon to position the probe in the region of tissue to be cauterized. The Thermal Cautery Probe features a handle, a finger/footswitch control and power cord for connection to a Starion Instruments power supply.
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K Number
K043155Device Name
STARION UNIVERSAL POWER SUPPLY (UPS)
Manufacturer
STARION INSTRUMENTS
Date Cleared
2004-12-09
(24 days)
Product Code
HQO, HOO
Regulation Number
886.4115Why did this record match?
Applicant Name (Manufacturer) :
STARION INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the simultaneous cutting and cauterization of soft tissue during surgery.
Device Description
The Starion Instruments Universal Power Supply (UPS) is a reusable, AC powered unit intended for use with cautery instruments incorporating Starion technology for the simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Universal Power Supply (UPS) features an on/off switch, green power-on LED indicator, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and an audible tone to indicate activation of the instrument heating element.
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K Number
K002547Device Name
STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
Manufacturer
STARION INSTRUMENTS
Date Cleared
2000-10-20
(64 days)
Product Code
HQP
Regulation Number
886.4115Why did this record match?
Applicant Name (Manufacturer) :
STARION INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000893Device Name
AC POWERED THERMAL CAUTERY UNIT
Manufacturer
STARION INSTRUMENTS
Date Cleared
2000-06-14
(86 days)
Product Code
HQO
Regulation Number
886.4115Why did this record match?
Applicant Name (Manufacturer) :
STARION INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001262Device Name
THERMAL CAUTERY FORCEPS
Manufacturer
STARION INSTRUMENTS
Date Cleared
2000-06-14
(56 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
STARION INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001273Device Name
STARION INSTRUMENTS POWER POINT CAUTERY CLAMP
Manufacturer
STARION INSTRUMENTS
Date Cleared
2000-06-14
(55 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
STARION INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000250Device Name
CAUTERY FORCEPS WITH FOOTSWITCH
Manufacturer
STARION INSTRUMENTS
Date Cleared
2000-03-07
(40 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
STARION INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000296Device Name
STARION CAUTERY HOOK
Manufacturer
STARION INSTRUMENTS
Date Cleared
2000-03-07
(36 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
STARION INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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