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510(k) Data Aggregation

    K Number
    K102403
    Device Name
    SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
    Manufacturer
    SAM MEDICAL PRODUCTS
    Date Cleared
    2011-03-03

    (191 days)

    Product Code
    NAD
    Regulation Number
    878.4020
    Why did this record match?
    Product Code :

    NAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used as an occlusive wound dressing. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.
    Device Description
    SAM Chest Seal with Valve: The SAM Chest Seal with valve is an adhesive dressing composed of a hydrogel based adhesive with a clear backing and check valve. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound. The one way valve prevents air pressure from increasing in the pleural space. SAM Chest Seal: The SAM Chest Seal is an adhesive dressing composed of a hydrogel based adhesive with a clear backing. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound.
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    K Number
    K091133
    Device Name
    APLION TOPICAL CARE SYSTEM
    Manufacturer
    APLION MEDICAL,LLC
    Date Cleared
    2009-05-20

    (30 days)

    Product Code
    NAD
    Regulation Number
    878.4020
    Why did this record match?
    Product Code :

    NAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.
    Device Description
    An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gasses such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing (21 CFR 878.4020). The Aplion Topical Care System ("Aplion System") consists of an occlusive wound dressing, a tubeset connection, and a small fluid-delivery component.
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    K Number
    K072560
    Device Name
    ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)
    Manufacturer
    TEIKOKU PHARMA USA, INC.
    Date Cleared
    2008-06-17

    (280 days)

    Product Code
    NAD
    Regulation Number
    878.4020
    Why did this record match?
    Product Code :

    NAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - For use in the management of psoriasis and the protection of psoriatic plaques - As a protective dressing - For management of superficial, dry to lightly exudating dermal wounds.
    Device Description
    Envela™ is substantially similar in terms of component materials, shape, dimensions, and mode of action to existing occlusive wound dressings.
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    K Number
    K060046
    Device Name
    DERMASTREAM
    Manufacturer
    ENZYSURGE, LTD.
    Date Cleared
    2006-02-27

    (52 days)

    Product Code
    NAD
    Regulation Number
    878.4020
    Why did this record match?
    Product Code :

    NAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments such as irrigating solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and allow debridement to facilitate the normal wound healing process.
    Device Description
    The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments. It is provided as a sterile, single-use, disposable device.
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    K Number
    K020781
    Device Name
    WET CHAMBER
    Manufacturer
    KINETIC CONCEPTS, INC.
    Date Cleared
    2002-05-06

    (56 days)

    Product Code
    NAD
    Regulation Number
    878.4020
    Why did this record match?
    Product Code :

    NAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KCI Wound Cell Transparent Dressing is intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Dressing may also be used as a secondary fixation device for other topical wound treatments such as antimicrobial and enzymatic debriding solutions and suspensions, alginates, gels and foams. The KCI Wound Cell Transparent Dressing is indicated for: - Non-exudating to minimally exuding wounds - Pressure sores - Lacerations/abrasions - Partial and full thickness wounds - Surgical incisions - Second degree burns - Donor sites - IV sites
    Device Description
    Occlusive Wound Dressing (21 CFR 878.4020) The KCI occlusive wound dressings differ in that the Wound Cell includes an injection port. This injection port facilitates the application of topical wound care products after the wound dressing has been placed over the wound to serve as a secondary fixation device in addition to its other intended uses.
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    K Number
    K990530
    Device Name
    KERLIX MD ANTIMICROBIAL GAUZE DRESSING
    Manufacturer
    THE KENDALL COMPANY, L.P.
    Date Cleared
    2000-01-31

    (346 days)

    Product Code
    NAD
    Regulation Number
    878.4020
    Why did this record match?
    Product Code :

    NAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KERUX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing
    Device Description
    The proposed Kerlix MD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with Polyhexamethylene Biguanide Hydrochloride. The dressing is packaged in Tyvek/Poly pouches as well as Tyvek/Styrene trays and is available in both sponge and roll form.
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    K Number
    K964534
    Device Name
    OTOSILK OTOLOGICAL GRAFT DRESSING
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-04-09

    (148 days)

    Product Code
    NAD
    Regulation Number
    878.4020
    Why did this record match?
    Product Code :

    NAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used as a temporary dressing in the external auditory canal following tympanoplasty or stapedectomy procedures.
    Device Description
    The OTOSILK™ Graft Dressing is a sterile, disposable graft dressing constructed of non-adherent material, designed for use with split thickness skin grafts used in procedures such as tympanoplasty, canalplasty, mastoid tympanoplasty, correction of congenital aural atresia, and removal of canal exostoses. Split thickness skin grafts may be taken from several sites, using either a razor blade or dermatome. The OTOSILK dressing will be used as a carrier for this skin graft to the ear canal. The graft is placed dermis side up on the dressing and the uncovered material is trimmed away. The skin graft and dressing are then applied to the canal. The dressing is removed from the canal one to two weeks post-operatively. The blue color of the OTOSILK Graft Dressing increases visualization of the dressing, ensuring total removal from the ear canal without disturbing the graft.
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