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510(k) Data Aggregation

    K Number
    K210615
    Device Name
    Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
    Date Cleared
    2022-05-13

    (438 days)

    Product Code
    Regulation Number
    882.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Thompson Surgical Instruments Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K151347
    Device Name
    MIS Spine Frame Instrument Case
    Date Cleared
    2015-10-16

    (149 days)

    Product Code
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    THOMPSON SURGICAL INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Thompson Surgical Instruments MIS Spine Frame Instrument Case is intended for use in healthcare facilities to store, transport, organize, and sterilize surgical instruments such as retractor frame components, lighting accessories, and blade or frame accessories between used in combination with an FDA cleared sterilization wrap. Validated sterilization parameters include pre-vacuum steam and gravity. | CYCLE | CYCLE TEMP | EXPOSURE TIME | DRY TIME | |-----------|---------------|---------------|------------| | Prevacuum | 132°C (270°F) | 4 Minutes | 30 Minutes | | Gravity | 121°C (250°F) | 30 Minutes | 30 Minutes |
    Device Description
    Thompson Surgical Instruments “MIS Spine Frame Instrument Case,” model 50000MSF, is intended to hold surgical instruments such as retractor blades, retractor frame components, lighting accessories, and blade or frame accessories during storage, transportation, and sterilization, as indicated. It is composed of materials that can be reused with steam sterilization methods and DCG graphics may be used. It has a distribution of perforations on the outer surfaces and between case levels that allow for optimal steam penetration. Vent to volume is .110. It is reusable and provided to the customer in a non-sterile conditions. This case can be described as an accessory for the Thompson Retractor.
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    K Number
    K080962
    Device Name
    LITE WAND II
    Date Cleared
    2008-06-25

    (82 days)

    Product Code
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    THOMPSON SURGICAL INSTRUMENTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Thompson Surgical Instruments, Inc. Lite Wand II intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor system which it can attach to through the use of a Cam Joint. The Lite Wand II is designed to provide visible illumination of the surgical field or the patient through a Halogen light source only. It is intended to be used with ACMI, Storz, Wolf, or Olympus connector cables. The Lite Wand II is intended to be used by surgeons and medical care practitioners in a surgical setting.
    Device Description
    Thompson Surgical Instruments, Inc. Lite Wand II is a fiber optic surgical light designed to provide visible illumination of the surgical field or the patient. The Lite Wand II consists of a Cam Joint fixture which attaches the device to a retractor system arm, a flexible "gooseneck" supported lighthead for easy positioning, and a fiber optic bundle. The Thompson surgical Lite Wand II is designed as a task light for surgical use. The Lite Wand II is designed to be a replacement or substitute for headlamps and it uses the same technology currently used in other headlamps and light sources. These other devices have similar performance characteristics which have been previously cleared by the FDA.
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