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510(k) Data Aggregation

    K Number
    K121441
    Device Name
    CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Date Cleared
    2012-07-20

    (66 days)

    Product Code
    HQP
    Regulation Number
    886.4115
    Why did this record match?
    Product Code :

    HQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.
    Device Description
    Bovie Cauteries are single use, battery operated devices. The device is activated by pressing the green button on the cautery body and is deactivated by releasing the button (in the default position, the cautery does not operate). Once the button is pressed, an internal circuit is completed that directs power from an internal battery to the cautery tip which in turn heats. The heated tip is introduced to the surgical site and the heat vaporizes the water component in blood/tissue, causing a clot that halts the bleeding.
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    K Number
    K083428
    Device Name
    F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
    Manufacturer
    FIAB SPA
    Date Cleared
    2009-09-01

    (286 days)

    Product Code
    HQP
    Regulation Number
    886.4115
    Why did this record match?
    Product Code :

    HQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required. Specially suitable for ophthalmology.
    Device Description
    Self-powered device for the cauterization of tissues and small vessels during surgery, without the use of a high frequency generator. The device is intended for use in ophthalmology. The system is started by pressing the button on the body of the cautery. The resistance of the wire of the tip, when the current passes, causes its heating guaranteeing its capacity of cauterization. The plastic and metal materials used in the devices comply with biocompatibility requisites. The energy produced by the continuous current is distributed as heat through a tip at a high temperature; the distribution is at short intervals of few seconds. The cautery has the weight, size and handle suitable to allow for easy use.
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    K Number
    K062659
    Device Name
    KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    2007-03-09

    (183 days)

    Product Code
    HQP, GEI, HOP
    Regulation Number
    886.4115
    Why did this record match?
    Product Code :

    HQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kirwan battery-powered cautery units are intended for general surgical use to cauterize small blood vessels in order to help reduce blood loss and keep the site clear of excess blood.
    Device Description
    Kirwan battery-powered cautery units are intended for general surgical use to cauterize small blood vessels in order to help reduce blood loss and keep the site clear of excess blood.
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    K Number
    K023506
    Device Name
    SURGICAL MEDICAL DEVICE CAUTERY
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2004-01-13

    (452 days)

    Product Code
    HQP
    Regulation Number
    886.4115
    Why did this record match?
    Product Code :

    HQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cause blood vessels to constrict and produce blood loss and keep the surgical field clear. Use for controlling diffuse bleeding and sculpting woven grafts.
    Device Description
    The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cause blood vessels to constrict and produce blood loss and keep the surgical field clear.
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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?
    Product Code :

    HQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994019
    Device Name
    CAUTERY GRASPER/DISSECTOR
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    2000-01-20

    (55 days)

    Product Code
    HQP
    Regulation Number
    886.4115
    Why did this record match?
    Product Code :

    HQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Simultaneous cutting and cauterization of soft tissue during surgery.
    Device Description
    The Starion Instruments thermal cautery grasper/dissector is a single use, hand-held surgical instrument intended for simultaneously cutting and cauterizing soft tissue during surgery. The Starion Instruments thermal cautery grasper/dissector contains handle controls that 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 finger switch, which activates a heating element in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.
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    K Number
    K990728
    Device Name
    THERMAL CAUTERY DEVICE, FORCEPS
    Manufacturer
    STARION INSTRUMENTS
    Date Cleared
    1999-06-03

    (90 days)

    Product Code
    HQP
    Regulation Number
    886.4115
    Why did this record match?
    Product Code :

    HQP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Simultaneous cutting and cauterization of soft tissue during surgery.
    Device Description
    Starion's Cautery Forceps and Battery Pack Power Supply are single use devices that are intended for the simultaneous cutting and coagulation of soft tissue during surgery, to be used in essentially all major surgical disciplines. Starion's Cautery Forceps are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics and target population of surgical disciplines. The principle of operation is that heat is conducted to the tissue via a small heater located at the tip of a hand-held, surgical instrument to provide cutting/cauterization.
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