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510(k) Data Aggregation

    K Number
    K984029
    Device Name
    SILGEL STC-S
    Manufacturer
    Date Cleared
    1999-08-05

    (266 days)

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

    NAGOR LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SILGEL™ STC-S is intended for use in the management of Keloid and Hypertrophic scars and associated erythema.
    Device Description
    Silgel™ STC-S consists of a high purity, medical grade silicone gel. The device will be sold non-sterile and supplied in aluminum tubes packaged into single unit cartons. Once applied to the skin according to the Instruction for Use the device does not need to be covered or held in place. Please note that the product is a device and not a pharmaceutical cream. It is not absorbed by the skin and functions as a membrane which retains moisture whilst permitting air to penetrate to the affected area.
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    K Number
    K974172
    Device Name
    SILGEL TOPICAL GEL SHEET
    Manufacturer
    Date Cleared
    1998-03-30

    (145 days)

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

    NAGOR LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Silgel™ device is intended for use in the management of hypertrophic and keloid scars. It can also be used for the prophylactic management of healed incisions for the prevention of hypertrophic or keloid scars. Silger™ helps relieve friction on newly healed scars when used as a splint lining insert.
    Device Description
    Silgel™. Topical Gel Sheet, consists of a durable medical grade silicone reinforced with polyester mesh. Sheets are protected on one side by a film which is removed before use and on the other by a paper backing. Sheets are individually packaged in grip seal bags. A sheet can be trimmed to the desired shape prior to placement on the scar. It is secured by wrapping with either gauze and hypoallergenic adhesive tape, light conforming crepe or tubular bandages, or compression garments. Firm pressure is not required for a therapeutic effect.
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