LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040314
    Device Name
    HEALICOLL
    Manufacturer
    ENCOLL CORP.
    Date Cleared
    2004-08-12

    (185 days)

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

    ENCOLL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Healicoll Topical Collagen Wound Dressing is intended for the topical wound management that includes: - Partial and full-thickness wounds. . - Pressure ulcers. . - Venous ulcers. . - Chronic vascular ulcers. . - Diabetic ulcers. . - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears), . - Surgical wounds (donor sites/grafts, post-Mohs' surgery, . post-laser surgery, podiatric, wound dehiscence)
    Device Description
    Helicoll is a translucent, off-white, semi-occlusive, self-adhering and ready to use pre-sterilized Type-1 Collagen Sheet for Second-degree Burn, Chronic Ulcers and other topical Wound Managements. Helicoll is flexible with moderate tackiness. Helicoll is a reconstituted collagen sheet free of contaminants like lipids, elastin and other immunogenic proteins. Helicoll maintains a physiologically moist microenvironment at the wound surface. This device is intended for one time use only.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1