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510(k) Data Aggregation

    K Number
    K991814
    Device Name
    MULTACHOICE INSTRUMENTS
    Manufacturer
    DEXIDE, INC.
    Date Cleared
    1999-06-23

    (27 days)

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

    DEXIDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MultAchoice Scissor Instrument: The MultAchoice Scissor may be used in a variety of endoscopic procedures. This device is designed for cutting or transecting tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Scissor has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery. MultAchoice Grasper Instrument: The MultAchoice Grasper may be used in a variety of endoscopic procedures. This device is designed for grasping and manipulating tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Grasper has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery. MultAchoice Dissector Instrument: The MultAchoice Dissector may be used in a variety of endoscopic procedures. This device is designed for blunt dissection, temporary grasping, and manipulation of tissue. It is fully autoclavable. The insulated shaft of this device has a 5mm OD and a 31cm working length. This shaft may be rotated 360° independent of the instrument handle, thereby permitting increased visibility and access to desired structures. The MultAchoice Dissector has been fitted with a standard banana plug to accept a monopolar connecting cable (not included) for electrosurgery.
    Device Description
    The MultAchoice™ Instruments are a set of reusable and configurable instruments consisting of a Handle, Insulated Shaft, and Instrument Insert that comprise a Laparoscopic Scissor, Grasper, and Dissector.
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    K Number
    K990379
    Device Name
    MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES
    Manufacturer
    DEXIDE, INC.
    Date Cleared
    1999-03-04

    (24 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEXIDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cannulas and accessories are to be used with a Dexide seal package and spike for creating a point of entry for laparoscopic instruments into the abdominal cavity and maintaining pneumoperitoneum. MultAport Cannulas: The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar Spike for creating a point of entry for laparoscopic instruments into the abdominal cavity. AccuPort 5-12mm Seal: The AccuPort Seal is a single-used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments with diameters ranging from 5mm to 12mm. Orbital Reducer Seal: The Orbital Reducer is a single used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments of equal and smaller size. Blunt Spike: The reusable Blunt Trocar spike is used with the MultAport Cannulas and AccuPort or Orbital Reducer Seal for creating a point of entry for laparoscopic instruments into the abdominal cavity. Sealing Cone: The Sealing Cone is a reusable product designed for use during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum. Shaft Seal (replacement part for Sealing Cone): The Sealing Cone is a reusable product designed for used during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum. The shaft seal is designed for use when sealing the cone to the cannula.
    Device Description
    The "candidate device" is a reusable, stainless steel Cannula anc disposable, single-use reduction seal system that threads into the Cannula. The reducer system is composed of silicon rubber, thermoplastic rubber, and plastics. The reusable Sealing Cone and its Seal accommodate the cannula to assist the surgical procedure.
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    K Number
    K981940
    Device Name
    MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES
    Manufacturer
    DEXIDE, INC.
    Date Cleared
    1998-09-25

    (115 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEXIDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The “candidate device” is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures. The "candidate device" is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage. The MultApump™ System is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.
    Device Description
    The “candidate device” consists of a Disposable Pump Head, pump motor, clamp & bracket, power supply and power cord(s) for use in laparoscopy. The Disposable Pump Head is a sterile, single-use device, composed of Stainless Steel, glass filled Polypropylene, Medical Grade EPDM, ABS plastic, plastic and flexible PVC tubing. It has an interface dock for attachments of the reusable pump motor. The pump motor, clamp, power supply and power cord are reusable components.
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    K Number
    K981941
    Device Name
    MULTAPORT CANNULA REDUCER AND ACCESSORIES
    Manufacturer
    DEXIDE, INC.
    Date Cleared
    1998-07-29

    (57 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEXIDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MultAport Cannulas: The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar Spike for creating a point of entry for laparoscopic instruments into the abdominal cavity. AccuPort 5-12mm Seal: The AccuPort Seal is a single-use device used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments with diameters ranging from 5mm to 12mm. Orbital Reducer Seal: The Orbital Reducer is a single used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments of equal and smaller size.
    Device Description
    The "candidate device" is a reusable, stainless steel Cannula and disposable, single-use reduction seal system that threads into the Cannula. The reducer system is composed of silicon rubber, thermoplastic rubber, and plastics. Accessories: Cannulas & Reduction Systems
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