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510(k) Data Aggregation

    K Number
    K222143
    Device Name
    APIS (R), VERIS (TM)
    Manufacturer
    Date Cleared
    2023-10-13

    (450 days)

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

    SweetBio, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Under the supervision of a healthcare professional. APIS® / VERIS™ Wound Management Devices are indicated for use in management of wounds, including: · Full and partial thickness wounds - · pressure ulcers (stages I -IV) - · venous stasis ulcers - · diabetic ulcers - abrasion - · surface wounds - · traumatic wounds (healing by secondary intention) - · donor site wounds - · surgical wounds For over-the-counter use, APIS® OTC / VERISTM OTC Wound Management Devices may be used for: - minor abrasions - · lacerations - minor cuts - · minor scalds and burns
    Device Description
    APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device for the management of wounds, are sterile, single-use devices. APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device are conformable solid sheets that are biodegradable and absorbable. APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device in its final form, is comprised of a highly purified collagen derivative from porcine skin (gelatin), Manuka honey, and hydroxyapatite (HAp). The intended use of APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device in the management of wounds is to cover and protect the wound, absorb wound exudate, and provide and maintain a moist wound environment. The structural reinforcement of APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device is achieved through the incorporation of hydroxyapatite into the crosslinked collagen derivative structure. The absorption and moisture-retaining properties are based on the manufacturing process and incorporation of honey into the crosslinked structure. The device is biodegradable and absorbs into the surrounding tissue. The degradation occurs through natural processes such as enzymatic breakdown, hydrolysis and other chemical/biological reactions depending on wound type and level of exudation. There is no difference between the APIS® Wound Management Device, VERIS™ Wound Management Device, APIS® OTC Wound Management Device and VERIS™ OTC Wound Management Device except APIS® Wound Management Device and APIS® OTC Wound Management Devices have a thickness of 0.03cm and is the compressed form of VERIS™ Wound Management Device and VERIS™ OTC Wound Management Devices which has a thickness of 0.6cm. In other words, VERIS™ Wound Management Devices and VERIS™ OTC Wound Management Devices are 20 times thicker than the APIS® Wound Management Devices and APIS® OTC Wound Management Devices (dressings).
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    K Number
    K182725
    Device Name
    Apis
    Manufacturer
    Date Cleared
    2019-05-31

    (245 days)

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

    SweetBio, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Apis is indicated for use in management of wounds, including - · full and partial thickness wounds - · pressure ulcers (stages I-IV) - venous stasis ulcers - · diabetic ulcers - abrasion - · surface wounds - · traumatic wounds (healing by secondary intention) - · donor site wounds - · surgical wounds
    Device Description
    Apis, for the management of wounds, is a sterile, single-use device. Apis is a conformable solid sheet that is biodegradable and absorbable. Apis, in its final form, is comprised of a highly purified collagen derivative (gelatin) from porcine skin, Manuka honey, and hydroxyapatite (HAp). The intended use of Apis in the management of wounds is to cover and protect the wound, absorb wound exudate, and provide and maintain a moist wound environment. The structural reinforcement of Apis is achieved through the incorporation of hydroxyapatite into the crosslinked collagen derivative structure. The absorption and moisture-retaining properties are based on the manufacturing process and incorporation of honey into the crosslinked structure. The device is biodegradable and absorbs into the surrounding tissue. The degradation occurs through natural processes such as enzymatic breakdown, hydrolysis and other chemical/biological reactions depending on wound type and level of exudation.
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