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510(k) Data Aggregation

    K Number
    K100912
    Device Name
    DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    2010-08-19

    (140 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIRWAN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes are intended to be connected to a nerve monitoring unit, such as the Neurosign 100 Nerve Monitor, which requires a standard 1.5mm DIN 42802 touch proof connector, in order to provide an electrical path by which electrical impulses may pass from the monitoring unit to the patient, thus effecting nerve stimulation to assist its user in locating and identifying motor nerves.
    Device Description
    The Kirwan 41-34XX Series of Disposable Nerve Stimulating Probes are surface electrodes used to stimulate nerves during various surgical procedures. They may be used on the surface of the skin, or on the surface of surgically exposed tissue, and as such, they are not intended nor designed to be inserted into tissue.
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    K Number
    K070360
    Device Name
    KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    2007-08-07

    (181 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIRWAN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These tubing sets are designed to function as Manifold Tubing for the CUSA EXcel™ Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate hand-piece, providing for both irrigation and aspiration of the surgical site.
    Device Description
    These tubing sets are designed to function as Manifold Tubing for the CUSA EXcel™ Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate handpiece, providing conduits for both irrigation and aspiration of the surgical site.
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    K Number
    K060915
    Device Name
    KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    2007-04-17

    (378 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIRWAN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurysms. They are also intended to be applied exclusively with the Kirwan 45.XXX and 65.XXX Series Appliers.
    Device Description
    The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurvsms. They are also intended to be applied exclusively with the 45.XXX and 65.XXX Series Appliers.
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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?
    Applicant Name (Manufacturer) :

    KIRWAN SURGICAL PRODUCTS, INC.

    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
    K052203
    Device Name
    AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    2005-10-20

    (69 days)

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

    KIRWAN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General purpose solid state bipolar generator to supply RF signal to electrosurgical hand-pieces used on soft body tissue where a wide range of tissue types, patient conditions and load impedances are encountered. Where applicable (i.e., Auraplus, 28-2600) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.
    Device Description
    The model 28-2000, Aura, 70 Watt Bipolar Electrosurgical Coagulator and the model 28-2600, Auraplus, 70 Watt Irrigating Bipolar Electrosurgical Coagulator model 20 2.000, haraphid state bipolar generators used to supply the RF signal to electrosurgical hand-pieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered. Where applicable (i.e., Auraplus) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.
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    K Number
    K023482
    Device Name
    AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    2003-01-15

    (90 days)

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

    KIRWAN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator is a general purpose solid state bipolar generator used to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
    Device Description
    The Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator, is a general purpose solid state bipolar generator used to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered. Its footswitch activation and solid state circuitry delivers low voltage RF/bipolar energy, interfacing with electrosurgical accessories via its standard female banana jacks. The Aura 20 differs technologically from its predicates with only minor operational features designed to enhance user interface. The following are some of those features. - While operating on both 115 and 230 VAC mains supply as its predicates, the Aura 20 does not require the placement of an external jumper in order to select between the two different voltage levels. - Activation of the Aura 20 is via footswitch only, eliminating the optional hand switch activation of its predicates, which is viewed as a little-used option and expendable in order to simplify construction, and limit size. - While similarly relying on solid-state electronics, the Aura 20 has been greatly simplified over its predicates by the use of microprocessor technology and modular medical-grade power supply. - The Aura 20 uses membrane keypads instead of potentiometers (knobs) as adjustable controls for tonal volume and power level settings.
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    K Number
    K992218
    Device Name
    DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    1999-07-30

    (29 days)

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

    KIRWAN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC - Bipolar System. This device is to be used to deliver electrical energy from a Malis™ CMC®-III (or equivalent) Generator to the bipolar forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.
    Device Description
    The Disposable Irrigation Bipolar Cord Assembly is a single-use product sold sterile, and is intended for use with standard bipolar irrigating forceps, and the Codman & Shurtleff, Malis™ CMC -Bipolar System. This device is to be used to deliver electrical energy from a Malis ™ CMC -III (or equivalent) Generator to the bipolar irrigating forceps (handpiece), as well as, provide the system with an integrated delivery conduit, for carrying an irrigating solution from its collapsible reservoir to the forceps, via gravity feed.
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    K Number
    K982176
    Device Name
    KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    1998-09-18

    (88 days)

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

    KIRWAN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kirwan Model 28 1500 Generator is a general purpose solid state monopolar generator with independent bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
    Device Description
    An isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator. The monopolar generator has continuously adjustable 0-150 watts in three cut modes of cut, blend 1, blend 2 and two coagulation modes 0-75 watts. The bipolar generator is continuously adjustable 0-50. Outputs of both generators are independently controlled and RF isolated from each other. Each generator handswitch system is powered by independent low voltage (7 Vdc) isolated power supplies. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) monopolar electrosurgerygenerators and bipolar coagulators.
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    K Number
    K971341
    Device Name
    KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    1997-05-22

    (42 days)

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

    KIRWAN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KIRWAN MODEL 28 1000 Generator is a general purpose solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
    Device Description
    A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms). A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation. The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply. Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines. IF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) ipolar coagulators.
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    K Number
    K965241
    Device Name
    BIPOLAR SUCTION COAGULATOR
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    1997-02-28

    (79 days)

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

    KIRWAN SURGICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.
    Device Description
    The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.
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