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510(k) Data Aggregation

    K Number
    K200455
    Device Name
    Trigger Switch and Cord
    Manufacturer
    New Deantronics Taiwan, Ltd.
    Date Cleared
    2020-03-31

    (35 days)

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

    New Deantronics Taiwan, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trigger Switch and Cord are accessories that are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic instruments is desired.
    Device Description
    The Trigger Switch and Cord are an electrical connecting cord assembly, intended to provide an electrical path between an RF electrosurgery generator and an RF surgical electrode. The insulated wire of the Cord is 10ft long. The Cord is intended to be plugged into an in-line Trigger Switch which is attached to the RF electrode handle with an adhesive backing. The Trigger Switch allows hand switching of the electrical current through the Cord during surgery. These devices can be used in hospitals and are used by trained professionals only. The Trigger Switch and Cord are compatible with the monopolar instruments with a shrouded 4mm male electrical connector and with an electrosurgical generator. Typically, these application devices are used in place of foot switches in the flow of electrosurgical current to the target site. These devices are sold as sterile, single-use devices.
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    K Number
    K153265
    Device Name
    New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
    Manufacturer
    New Deantronics Taiwan, Ltd.
    Date Cleared
    2016-01-05

    (54 days)

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

    New Deantronics Taiwan, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable laparoscopic electrodes are intended for use in minimally invasive surgical procedures where monopolar electrosurgical cutting and coagulation are desired.
    Device Description
    The disposable laparoscopic electrodes are classified by FDA as an "Electrosurgical, Cutting & Coagulation Device and Accessories", under the General & Plastic Surgery Panel, Product Code GEI, Regulation number 878.4400, Class II, panel 79. The devices are provided to healthcare professional only. The New Deantronics disposable laparoscopic electrodes are used in conjunction with monopolar electrosurgical pencils that accept 2.36 mm connectors, trocars or cannulas with appropriate 5 mm adapters, electrosurgical generator, and patient return electrode. During the operation, the electrode and the insulated shaft are to be inserted through a trocar and the conductive shaft end is inserted into the nose of the electrosurgical pencil from which it receives the high frequency current while contacting target tissue for cutting and coagulation in laparoscopic procedure. The New Deantronics laparoscopic electrodes are single use. The New Deantronics laparoscopic electrodes consists of four distinct sections, including a conduction insulated shaft, a conductive shaft end, and an electrode tip and a shaft end protector. There are two groups of laparoscopic electrodes, including non-coated and coated laparoscopic electrodes. The coated laparoscopic electrodes have the same configuration but the electrode tips are coated with non-sticking coating material. The devices are available in five electrode tip configurations and two different shaft lengths. There are sixteen models of New Deantronics laparoscopic electrodes available.
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    K Number
    K152031
    Device Name
    New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.
    Manufacturer
    NEW DEANTRONICS TAIWAN, LTD.
    Date Cleared
    2015-09-17

    (57 days)

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

    NEW DEANTRONICS TAIWAN, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The New Deantronics Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil, improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator.
    Device Description
    The Smoke Evacuation Adapter is a single-use device provided to healthcare professionals. This device is an accessory to an electrosurgical pencil. The Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator. The device components include a pencil holding clamp, an electrosurgical pencil wire holder, smoke evacuator tubing pathway to the smoke evacuator, and a connector to the smoke evacuator. The clamp secures the smoke evacuation pencil adapter to the bottom of the pencil handle. Suction to remove smoke and odors is created by a smoke evacuator device furnished by the user organization. The smoke evacuator maintains a low pressure condition by a suction pump.
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    K Number
    K982748
    Device Name
    BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224
    Manufacturer
    NEW DEANTRONICS TAIWAN, LTD.
    Date Cleared
    1998-11-03

    (89 days)

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

    NEW DEANTRONICS TAIWAN, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgical accessory. BiPolar Cord Set for use with foot switching electrosurgical accessories to conduct high-frequency electrical current intended to remove tissue and control bleeding.
    Device Description
    New Deantronics, Inc. Model SB 223 and SB 224 BiPolar Cord Sets.
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    K Number
    K982742
    Device Name
    DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE HOLSTER MODELS SB 313 RS, SB 313 RSH
    Manufacturer
    NEW DEANTRONICS TAIWAN, LTD.
    Date Cleared
    1998-09-14

    (39 days)

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

    NEW DEANTRONICS TAIWAN, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Device Description
    Disposable Hand Switching Pencil, Rocker Switch, One Piece
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    K Number
    K982743
    Device Name
    DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH
    Manufacturer
    NEW DEANTRONICS TAIWAN, LTD.
    Date Cleared
    1998-09-14

    (39 days)

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

    NEW DEANTRONICS TAIWAN, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Device Description
    Model SB 313 PB and SB 313 PBH Disposable Hand Switching Pencil, Push Button, One Piece Body. With and Without Holster
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    K Number
    K982746
    Device Name
    MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1
    Manufacturer
    NEW DEANTRONICS TAIWAN, LTD.
    Date Cleared
    1998-09-14

    (39 days)

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

    NEW DEANTRONICS TAIWAN, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgical accessory. Monopolar electrosurgical coagulator for controlling bleeding by use of high-frequency electrical current and a suction tube for removal of fluids and debris from the surgical site.
    Device Description
    Monopolar Suction Coagulator
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    K Number
    K982749
    Device Name
    MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2
    Manufacturer
    NEW DEANTRONICS TAIWAN, LTD.
    Date Cleared
    1998-09-14

    (39 days)

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

    NEW DEANTRONICS TAIWAN, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgical accessory. A foot activated electrosurgical pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Device Description
    Monopolar Foot Control Pencil, Model # SB 112-2
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    K Number
    K982744
    Device Name
    DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH
    Manufacturer
    NEW DEANTRONICS TAIWAN, LTD.
    Date Cleared
    1998-09-11

    (36 days)

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

    NEW DEANTRONICS TAIWAN, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgical accessory. Hand switching, disposable pencil intended to remove the survey of the comments of and stricel overant Electrosurgicul accousery. Thanks of high-frequency electrical current.
    Device Description
    Model SB 312 PB and SB 32 PBH Disposable Hand Switching Pencil, Push Button, Two Piece Body, With and Without Holster
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