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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
    K182737
    Device Name
    3T 32 Channel Head Coil
    Manufacturer
    Date Cleared
    2019-04-12

    (196 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nova Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nova Medical 3T 32 Channel Head Coil is to be used in conjunction with a Magnetic Resonance (MR) Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis. Model # 3832016 is used with GE 3T MRI Scanner Discovery MR750. Model # 38320169 is used with GE 3T MR Scanners Signa Architect, Discovery MR750W and Signa PET/MR.
    Device Description
    The Nova Medical 3T 32 Channel Head Coil is receive only MR coil for imaging the human head when used with GE Healthcare 3T MR Systems. The head coil has 32 RF elements that are tuned to 127.75 MHz. The head coil is constructed of a two part rigid plastic housing with an opening for patient viewing and comfort. The 3T 32 Channel Head Coil comprises a split design for easy patient positioning, measures approximately 17.5" long x 12″ high x 15″ wide without the tray and has an approximate weight of 20 lbs. The device comes with optional accessories; Mirror for patient viewing and Foam Cushions for patient comfort and head positioning.
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