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510(k) Data Aggregation

    K Number
    K243181
    Device Name
    Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
    Date Cleared
    2024-10-31

    (31 days)

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

    Bionova Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Foundation DRS+ Solo is indicated for the management of wounds including: - · Full thickness and partial thickness wounds - Pressure ulcers - Venous ulcers - · Ulcers caused by mixed vascular etiologies - Diabetic ulcers - · First dearee burns - · Partial thickness burns (superficial second-degree burns) - · Donor sites and other bleeding surface wounds - · Abrasions - · Trauma wounds (abrasions, lacerations, skin tears) - · Dehisced wounds - · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) Foundation DRS+ Solo may be cut to size.
    Device Description
    Foundation DRS+ Solo is a conformable, advanced wound care device that consists of a porous matrix of chitosan derived from shellfish, sodium chondroitin sulfate, a glycosaminoglycan, and hyaluronic acid. The chitosan- glycosaminoglycan- hyaluronic acid biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.
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    K Number
    K240298
    Device Name
    Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
    Date Cleared
    2024-08-21

    (202 days)

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

    Bionova Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Foundation DRS+ Duo is indicated for the management of wounds including: - · Full thickness and partial thickness wounds - Pressure ulcers - Venous ulcers - · Ulcers caused by mixed vascular etiologies - · Diabetic ulcers - · First degree burns - · Partial thickness burns (superficial second-degree burns) - · Donor sites and other bleeding surface wounds - · Abrasions - · Trauma wounds (abrasions, lacerations, skin tears) - · Dehisced wounds - · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) Foundation DRS+ Duo may be cut to size.
    Device Description
    Foundation DRS+ Duo is a conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish, sodium chondroitin sulfate, a glycosaminoglycan, and hyaluronic acid. The chitosan- glycosaminoglycan- hyaluronic acid biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades. The Foundation DRS+ Duo has a semipermeable polyurethane backing layer (offered with or without perforations) providing a flexible covering for the wound surface.
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    K Number
    K231937
    Device Name
    Foundation Dermal Regeneration Scaffold (DRS) Solo
    Date Cleared
    2023-11-13

    (136 days)

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

    Bionova Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Foundation DRS Solo is indicated for the management of wounds including: - · Full thickness and partial thickness wounds - Pressure ulcers - Venous ulcers - · Ulcers caused by mixed vascular etiologies - · Diabetic ulcers - · Partial thickness burns (superficial second-degree burns) - Donor sites and other bleeding surface wounds - · Abrasions - · Trauma wounds (abrasions, lacerations, skin tears) - Dehisced wounds - · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) Foundation DRS Solo may be cut to size.
    Device Description
    Foundation DRS Solo is a highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.
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