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510(k) Data Aggregation

    K Number
    K071832
    Device Name
    MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM
    Manufacturer
    MEDICAL SCIENTIFIC, INC.
    Date Cleared
    2007-09-18

    (77 days)

    Product Code
    LJH, KOG
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide irrigation during endoscopic surgical procedures
    Device Description
    Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures. The system is compromised of a pump, foot pedal, and power cord. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed.
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    K Number
    K063700
    Device Name
    SPYGLASS IRRIGATION SYSTEM
    Manufacturer
    MEDICAL SCIENTIFIC, INC.
    Date Cleared
    2007-02-08

    (57 days)

    Product Code
    LJH, KOG
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide irrigation during endoscopic surgical procedures
    Device Description
    Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures. The system is compromised of a pump, foot pedal, and a sterile single use disposable tubing set. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. The pump provides an adjustable flow-rate from 0 - 45 ml/min at 45 psi. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed. The tubing set will mate with a standard bottle of sterile water or saline and is provided sterile. A portion of the tubing set is placed in the peristaltic pump for flow creation.
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    K Number
    K031564
    Device Name
    CSS
    Manufacturer
    MEDICAL SCIENTIFIC, INC.
    Date Cleared
    2003-10-07

    (141 days)

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

    MEDICAL SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during various arthroscopic surgical procedures.
    Device Description
    The CSS is an accessory device that is intended to be used in conjunction with currently marketed automated debrider systems and ESU's the same as the current MSI Bipolar Sheath. The CSS is designed to fit directly over various sizes of straight automated debrider system blades. The CSS will be available in a variety of diameters and in lengths. When the CSS is inserted over one of the debrider blades, the device may be used to cauterize tissue. The CSS can be utilized to provide spot coagulation or to coagulate tissue while the debrider blade is in operation.
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    K Number
    K011202
    Device Name
    MSI BIPOLAR SHEATH
    Manufacturer
    MEDICAL SCIENTIFIC, INC.
    Date Cleared
    2001-12-31

    (256 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K981387
    Device Name
    EVANESCE SCAR MANAGEMENT SYSTEM
    Manufacturer
    MEDICAL SCIENTIFIC, INC.
    Date Cleared
    1998-06-10

    (55 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Evanesce Scar Management System is intended for the over the counter topical management of Hypertrophic and Keloid Scars
    Device Description
    The Evanesce Scar Management System is composed of a sheet of soft, flexible, translucent silicone elastomer.
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