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Found 6 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?
Product Code :
HQO
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
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?
Product Code :
HQO
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
K002341Device Name
THERMAL CAUTERY UNIT, MODEL 150
Manufacturer
GEIGER MEDICAL TECHNOLOGIES, INC.
Date Cleared
2000-10-23
(83 days)
Product Code
HQO
Regulation Number
886.4115Why did this record match?
Product Code :
HQO
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?
Product Code :
HQO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K971538Device Name
MENTOR GEMINI HEMOSTATIC ERASER
Manufacturer
MENTOR OPHTHALMICS, INC.
Date Cleared
1997-07-14
(77 days)
Product Code
HQO
Regulation Number
886.4115Why did this record match?
Product Code :
HQO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy.
Device Description
The MENTOR® GEMINI™ HEMOSTATIC ERASER™ is a hand-held bipolar probe used for coagulation which consists of (a) a handle and (b) a disposable tip (electrode). The handle transfers RF energy to the disposable tip via a unique electrical contact system located in the internal cavity of the handle. After a single use, the Tip is intended to be disposed of in a safe and cost effective manner. The handle is intended to be used 1-50 times before discarding.
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K Number
K962135Device Name
D.O.R.C. MICRODIATHERMY SYSTEM
Manufacturer
DUTCH OPHTHALMIC USA, INC.
Date Cleared
1996-08-29
(87 days)
Product Code
HQO
Regulation Number
886.4115Why did this record match?
Product Code :
HQO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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