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510(k) Data Aggregation

    K Number
    K982804
    Device Name
    SPYROGEL HYDROGEL WOUND AND BURN DRESSING
    Date Cleared
    1998-12-16

    (128 days)

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

    INNOVATIVE TECHNOLOGIES (US), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The following indications for use are for Over The Counter Use: Superficial Abrasions, Scrapes, Cuts, and Lacerations Minor Burns and scalds
    Device Description
    Spyrogel Hydrogel Wound and Burn Dressings are sterile individually packaged hydrogel dressings.
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    K Number
    K980673
    Device Name
    SPYROSORB FOAM ISLAND WOUND DRESSING
    Date Cleared
    1998-05-21

    (90 days)

    Product Code
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE TECHNOLOGIES (US), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Spyrosorb Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of partial and full thickness wounds. The following indications for use are for Prescription Use or under the direction of a health care professional: Venous stasis ulcers Diabctic ulcers Pressure sores Donor sites Burus, Minor and Chemical Abrasions and laccrations Incisions The following indications for use are for Over The Counter Use: Superficial Abrasions, Scrapes, Cuts, and Laccrations Minor Burns
    Device Description
    Spyrosorb Foam Island Wound Dressings are sterile, absorplive dressings. Spyrosorb combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable. The wound contact surface of Spyrosorb is an absorptive foam island dressing. A second layer consisting of a microporous polyurethane self adhesive membrane facilitates the case of application to the wound site. The outcrmost layer acts as a barner to exogenous moisture and bacteria while allowing permeability to moisture vapor and oxygen.
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    K Number
    K974520
    Device Name
    SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
    Date Cleared
    1998-02-06

    (66 days)

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

    INNOVATIVE TECHNOLOGIES (US), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prescription Use: SPYROFLEX Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: Venous stasis ulcers, Diabetic ulcers, Pressure sores, Donor sites, Blisters, Incisions, Severe sunburn, Poison Ivy, Partial-thickness wounds, Superficial burns, Abrasions and lacerations, Full-thickness wounds, Skin tears, Dermal lesions, Minor chemical burns, Thermal burns. Over-The-Counter Use: SPYROFLEX Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of the following: Abrasions, Superficial Blisters, Minor Burns, Superficial Cuts, Superficial Lacerations, Superficial Scrapes, Minor Rash.
    Device Description
    SPYROFLEX Foam Island Wound Dressings are sterile, absorptive dressings. SPYROFLEX combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable. The wound contact surface of SPYROFLEX is an absorptive foam island dressing. A second layer consisting of a microporous polyurethane self adhesive membrane facilitates the ease of application to the wound site. This layer is moisture vapor permeable and impermeable to microorganisms and liquids.
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