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510(k) Data Aggregation

    K Number
    K110355
    Device Name
    VENX REVOLUTION
    Manufacturer
    VENX LLC
    Date Cleared
    2011-04-22

    (74 days)

    Product Code
    GAH
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body.
    Device Description
    The VENX REVOLUTION™ is a sterile, disposable, single patient use surgical instrument for the disruption and destruction of spider veins located in the lower extremities of the body. The device is made available in several sizes to accommodate a range of veins that form in the lower body. The VENX REVOLUTION™ consists of a thermoplastic handle containing a lever actuated rack and gear mechanism for rotating a shaft extending from the handle. At the end of the shaft are stainless steel, needle-like tines sharpened and spaced appropriately to straddle veins located just below the surface of the skin. Once the tines are in place straddling the vein, the levers are actuated causing the shaft to rotate approximately 360° or more. Actuating the levers causes internal springs to compress. Once the levers have rotated the shaft 360° and the tines have disrupted the vein, releasing the levers allows the compressed springs to return the tines to their original position. The device is then withdrawn and re-inserted at another position within the clinician-selected area to repeat the operation on the same vein or on another vein. The procedure is repeated until all veins within the selected area have been treated.
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    K Number
    K000932
    Device Name
    ARACHNOPHLEBECTOMY NEEDLE
    Manufacturer
    ADVANCED MEDICAL PRODUCTS, INC.
    Date Cleared
    2000-05-17

    (55 days)

    Product Code
    GAH
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970306
    Device Name
    MARKMAN TEMPLATE SYSTEM
    Manufacturer
    BARRY MARKMAN, M.D.
    Date Cleared
    1997-11-20

    (297 days)

    Product Code
    GAH
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Template System will be used solely for hair restoration. The device will first create slits in a recipient site in the scalp, and then insert hair grafts into these slits. Cartridges preloaded with hair grafts will facilitate insertion in an efficient manner.
    Device Description
    The Template System will be used solely for hair restoration. The device will first create slits in a recipient site in the scalp, and then insert hair grafts into these slits. Cartridges preloaded with hair grafts will facilitate insertion in an efficient manner.
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    K Number
    K972918
    Device Name
    RAPID FIRE HAIR IMPLANTER CAROUSEL
    Manufacturer
    APEX MEDICAL PRODUCTS, LLC.
    Date Cleared
    1997-10-27

    (81 days)

    Product Code
    GAH, PAN
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is in ended to be used for hair transplantation on the scalp. The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is indicated where patients require one or more hair grafting sessions during which multiple grafts have to be implanted.
    Device Description
    The RAPID FIRE HAIR IMPLANTER CAROUSEL™ (Carousel) is a disposable mechanical device designed to facilitate a hair transplant. It consists of a circular Carousel designed to house hair grafts, a sharp end designed to create an opening in the skin of the scalp and a button end that activates the moving parts within the Carousel. The CAROUSEL consists of a stainless steel blade and the body composed of Lustran 348 resin.
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    K Number
    K972521
    Device Name
    NAVIGATOR (STYLET) 2006
    Manufacturer
    SIL-MED CORP.
    Date Cleared
    1997-10-01

    (86 days)

    Product Code
    GAH
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Navigator (stylet) is a stainless steel wire rod, inserted into the catheter to assist with insertion and placement of the catheter in the peritoneum.
    Device Description
    Stainless steel wire rod intended to aid in the manipulation of or insertion of the catheter for placement in the peritoneum.
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