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510(k) Data Aggregation

    K Number
    K070871
    Device Name
    STARION UNIVERSAL POWER SUPPLY
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2007-04-13

    (15 days)

    Product Code
    HQO
    Regulation Number
    886.4115
    Why 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
    K062257
    Device Name
    STARION INSTRUMENTS THERMAL LITIGATING SHEARS
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2006-10-10

    (67 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why 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
    K050308
    Device Name
    THERMAL CAUTERY PROBE
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2005-02-25

    (17 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Why 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
    K043155
    Device Name
    STARION UNIVERSAL POWER SUPPLY (UPS)
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2004-12-09

    (24 days)

    Product Code
    HQO, HOO
    Regulation Number
    886.4115
    Why 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
    K002547
    Device Name
    STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2000-10-20

    (64 days)

    Product Code
    HQP
    Regulation Number
    886.4115
    Why 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
    K000893
    Device Name
    AC POWERED THERMAL CAUTERY UNIT
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2000-06-14

    (86 days)

    Product Code
    HQO
    Regulation Number
    886.4115
    Why 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
    K001262
    Device Name
    THERMAL CAUTERY FORCEPS
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2000-06-14

    (56 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why 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
    K001273
    Device Name
    STARION INSTRUMENTS POWER POINT CAUTERY CLAMP
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2000-06-14

    (55 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why 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
    K000250
    Device Name
    CAUTERY FORCEPS WITH FOOTSWITCH
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2000-03-07

    (40 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why 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
    K000296
    Device Name
    STARION CAUTERY HOOK
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2000-03-07

    (36 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    STARION INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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