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510(k) Data Aggregation

    K Number
    K962544
    Device Name
    MICRO DIAMOND-POINT DISSECTION NEEDLES
    Manufacturer
    Date Cleared
    1996-09-20

    (84 days)

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

    DSP WORLDWIDE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles are electrosurgical electrodes which are intended for use as accessories to electrosurgical devices to cut tissue (dissection) and control bleeding for general, plastic, and reconstructive surgery.
    Device Description
    The DSP Worldwide Suowden-Pencer Micro Diamond-Point™ Dissection Needles are inserted into the electrosurgical handpiece. As with all other electrosurgical electrodes, energy is applied to the tissuc with the highest concentration at the tip of the electrode. The Micro Diamond-Pointer Dissection Needles are provided in a variety of lengths and contigurations The electricie of a tungeten needlo rip inserted into a stainless steel sleeve. This needle assembly is then covered with two layers of heat shrink tubing for insulation. Micro Diamond-Point™ Dissection Needless are provided nonsterile, for single use only. Devices are provided three per package and require sterilization prior to use. Sterilization instructions are provided in device labeling.
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    K Number
    K962371
    Device Name
    DERMTOME BLADE
    Manufacturer
    Date Cleared
    1996-08-29

    (71 days)

    Product Code
    Regulation Number
    878.4820
    Why did this record match?
    Applicant Name (Manufacturer) :

    DSP WORLDWIDE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes.
    Device Description
    The DSP Worldwide Snowden-Pencer Dermatome Blade is secured to the Padgett Dermatome head using the securing nut. The blade oscillates on the horizontal plane to harvest a split thickness of skin from a donor site for grafting. It is provided in one size only and consists of the stainless steel used for many surgical applications. Blades are provided sterile, single use, and disposable in individual Tyvek and polypropylene pouches. Devices are sterilized using gamma sterilization.
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    K Number
    K962365
    Device Name
    XENON LIGHTSOURCE
    Manufacturer
    Date Cleared
    1996-07-18

    (29 days)

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

    DSP WORLDWIDE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DSP Worldwide Snowden-Pencer Xenon Lightsource is intended for use as an accessory to fiberoptic endoscopes to provide illumination during endoscopic procedures.
    Device Description
    The DSP Worldwide Snowden-Pencer Xenon Lightsource is a fiberoptic illuminator for use in endoscopic surgical procedures. The device includes a Power Switch/Circuit Breaker, Light Guide receptacle which accepts the fiber optic cables (designed to accept ACMI cables with Storz, Olympus, and Wolf adapters also available), Lamp Usage Clock which indicates elapsed bulb usage (in hours), Light Intensity Control which allows illumination to be adjusted (clockwise to increase intensity and counterclockwise to decrease intensity), Light Intensity Indicator which provides a graphic representation of the level of light intensity, a Lamp Door on the side of the unit to provide access for replacement of the lamp module, a Cooling Fan to cool the Xenon bulb and the power supply of the unit. Detailed specifications for the Lightsource were provided.
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