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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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    K Number
    K123961
    Device Name
    SENTREX BIOSPONGE MPD
    Date Cleared
    2013-04-05

    (100 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
    The Sentrex BioSponge MPD is indicated in the dressing and management of: - Full thickness and partial thickness wounds . - . Pressure ulcers - Venous ulcers . - . Ulcers caused by mixed vascular etiologies - Diabetic ulcers - First and second degree burns . - . Donor sites and other bleeding surface wounds - . Abrasions - . Trauma wounds healing by secondary intention - Dehisced wounds . - . Surgical wounds - Dehisced surgical wounds - Grafts The Sentrex BioSponge MPD may be cut to size. The Sentrex BioSponge MPD is indicated for wounds with moderate to high amounts of exudate, and may be used in conjunction with negative pressure wound therapy (NPWT).
    Device Description
    The Sentrex BioSponge MPD is a sterile, porous, soft chitosan sponge dressing that provides a moist healing environment to support wound healing. The dressing is made of chitosan, a naturally occurring, biodegradable, biocompatible polysaccharide derived from shellfish. The shells are processed and chemically treated. Once in bandage form, they are sterilized by gamma irradiation and packed in a heat-sealed foil laminate pouch. The Sentrex BioSponge MPD may be moistened with saline in accordance with physician recommendation. When moistened, the Sentrex BioSponge MPD is a highly conformable dressing that maintains contact with the wound surface. The Sentrex BioSponge MPD provides a moist wound environment, which may help minimize wound trauma at dressing changes. In vivo data has shown that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT). The Sentrex BioSponge MPD is provided in the following sizes (I x w x h): 2.5cm x 10cm x 0.6cm 2.5cm x 20cm x 0.6cm 5cm x 5cm x 0.6cm 5cm x 10cm x 0.6cm 5cm x 15cm x 0.6cm 10cm x 10cm x 0.6cm 10cm x 15cm x 0.6cm 10cm x 20cm x 0.6cm 2.5cm x 10cm x 1cm 2.5cm x 20cm x 1cm 5cm x 5cm x 1cm 5cm x 10cm x 1cm 5cm x 15cm x 1cm 10cm x 10cm x 1cm 10cm x 15cm x 1cm 10cm x 20cm x 1cm
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    K Number
    K112191
    Device Name
    HEALEX BIOSPONGE WOUND DRESSING
    Date Cleared
    2012-06-05

    (312 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
    The Sentrex BioSponge Wound Dressing is indicated in the dressing and management of: - Full thickness and partial thickness wounds - Pressure ulcers - Venous ulcers - Ulcers caused by mixed vascular etiologies - Diabetic ulcers - First and second degree burns - Donor sites and other bleeding surface wounds - Abrasions . - Trauma wounds healing by secondary intention - Dehisced wounds - Surgical wounds - Dehisced surgical wounds
    Device Description
    The Sentrex BioSponge Wound Dressing is a sterile, porous, soft chitosan sponge dressing that provides a moist healing environment to support wound healing. The Sentrex Wound Dressing is provided dry, in 10 cm x 10 cm and 5 cm x 5 cm squares. The dressing is made of chitosan, a naturally occurring, biocompatible polysaccharide derived from shellfish. The shells are processed and chemically treated. Once in bandage form, they are sterilized by gamma irradiation and packed in a heat-sealed foil laminate pouch. The Sentrex Wound Dressing may be moistened with saline in accordance with physician recommendation.
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