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510(k) Data Aggregation

    K Number
    K251845
    Device Name
    Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
    Manufacturer
    Kerecis Limited
    Date Cleared
    2025-07-16

    (30 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250329
    Device Name
    GeniPhys Collymer Self-Assembling Scaffold
    Manufacturer
    GeniPhys, Inc.
    Date Cleared
    2025-06-25

    (140 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collymer Self-Assembling Scaffold is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.
    Device Description
    Collymer Self-Assembling Scaffold is a wound management device composed of a purified, self-assembling (scaffold-forming) collagen derived from porcine dermis. This two-part device consists of a collagen solution and a self-assembly reagent. Combining the two solutions initiates collagen self-assembly. The resulting collagen scaffold is suitable for cellularization and vascularization, providing a moist wound environment.
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    K Number
    K242985
    Device Name
    CollOvine™ Wound Dressing
    Manufacturer
    OviGenex LLC
    Date Cleared
    2025-06-20

    (267 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CollOvine™ Wound Dressing is indicated for the management of exuding wounds including: - full-thickness & partial-thickness wounds - pressure ulcers - venous ulcers - ulcers caused by mixed vascular etiologies - diabetic ulcers - superficial second-degree burns - donor sites and other bleeding surface wounds - abrasions - traumatic wounds healing by secondary intention - dehisced surgical incisions
    Device Description
    CollOvine Wound Dressing is a sterile advanced wound care device composed of medical grade ovine collagen. CollOvine Wound Dressing is soft, absorbent, and readily conforms to the wound bed. CollOvine Wound Dressing is available in multiple sizes; 1"x1", 2"x2" and 4"x4". CollOvine wound dressing is intended to maintain the moist microenvironment. CollOvine Wound Dressing is a primary wound dressing that can be cut with sterile scissors to ensure good contact with the wound bed. CollOvine Wound Dressing should be used with suitable non-occlusive absorbent secondary dressing and secured with standard non-irritating fixations such as medical grade tape or semi-occlusive dressing as appropriate. CollOvine Wound Dressing is a primary dressing, to maintain the required moist wound bed environment. CollOvine Wound Dressing is soft and pliable. The ovine collagen for CollOvine Wound dressing is obtained from sheep in compliance with ISO22442, including controls of animal tissue sourcing, collection, storage and viral inactivation.
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    K Number
    K241904
    Device Name
    DermiSphere Dermal Template
    Manufacturer
    FesariusTherapeutics Inc.
    Date Cleared
    2025-01-06

    (189 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DermiSphere™ hDRT hydrogel Dermal Regeneration Template is a wound dressing indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second degree burns, skin tears) and draining wounds. This device is intended for one-time use.
    Device Description
    DermiSphere™ hDRT hydrogel Dermal Regeneration Template is an advanced wound dressing comprised of crosslinked bovine collagen microspheres embedded in bovine collagen hydrogel matrix. This composite biodegradable wound dressing provides a scaffold for native tissue cellular invasion and capillary growth.
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    K Number
    K243071
    Device Name
    Bovine Dermis Collagen Dermal Matrix
    Manufacturer
    Collagen Matrix, Inc.
    Date Cleared
    2024-12-19

    (83 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bovine Dermis Collagen Dermal Matrix is indicated for the management of wounds, including: - . Full thickness and Partial thickness wounds - . Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers) - . Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) - . Trauma wounds (abrasions, lacerations, and skin tears) - Draining wounds - Partial thickness burns
    Device Description
    Bovine Dermis Collagen Dermal Matrix is an absorbent, porous, collagen matrix engineered from purified collagen derived from bovine dermal tissue. Bovine Dermal Matrix should be applied directly to the wound, covering the entire wound surface. Bovine Dermis Collagen Dermal Matrix is supplied sterile, non-pyrogenic and for single use only.
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    K Number
    K242146
    Device Name
    BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
    Manufacturer
    Smith & Nephew Medical Limited
    Date Cleared
    2024-12-17

    (147 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIOBRANE Dressings are indicated for: - Covering clean partial thickness burn wounds - Split thickness donor sites BIOBRANE Glove is indicated for: - Covering clean partial thickness burn wounds of the hand.
    Device Description
    BIOBRANE Dressing and BIOBRANE Glove are wound dressings made from an ultrathin, semipermeable, perforated silicone membrane that is mechanically bonded to a flexible knitted tri-filament nylon fabric. Denatured porcine dermal collagen is bonded to the silicone-nylon membrane to provide a flexible and conformable dressing with adherence properties and a hydrophilic surface.
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    K Number
    K233378
    Device Name
    ABCcolla® Collagen ADM Scaffold
    Manufacturer
    ACRO Biomedical Co., Ltd.
    Date Cleared
    2024-10-18

    (382 days)

    Product Code
    KGN, DAT
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ABCcolla® Collagen ADM Scaffold is intended to be used for management of wounds. including venous ulcers, pressure ulcers, chronic vascular ulcers, diabetic ulcers, tunneled undermined wounds (donor site/ grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), first and second-degree burns, draining wounds.
    Device Description
    ABCcolla® Collagen ADM Scaffold is a decellularized porcine collagen biomaterial from porcine dermis. When applied on a wound, this product helps absorb wound exudates and maintain a moist wound environment.
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    K Number
    K242828
    Device Name
    Corplex P/ Theracor P/ Allacor P
    Manufacturer
    StimLabs, LLC
    Date Cleared
    2024-10-18

    (29 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Corplex P/Theracor P/Allacor P is indicated for use in the management of the following wounds: - · Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - · Diabetic ulcers - · Chronic vascular ulcers - · Tunneled/undermined wounds - · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) - · Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears) - · Draining wounds
    Device Description
    Corplex P/Theracor P/Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
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    K Number
    K241080
    Device Name
    Kerecis Parvus (50207)
    Manufacturer
    Kerecis Limited
    Date Cleared
    2024-08-21

    (124 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Management of wounds including: - Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - Chronic vascular ulcers - Diabetic ulcers - Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears) - Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) - Draining wounds
    Device Description
    Kerecis "Parvus™ is a lyophilized, terminally sterilized, acellular, particulate fish skin medical device comprised of biocompatible, non-crosslinked, resorbable, acellular fish skin (North Atlantic Cod) for wound management. The device is intended for single use only. The subject device is packaged in the following weights: 100mg (4 cm2) 200mg (8 cm2) 500mg (19 cm²) 1000mg (38 cm²) 2,500mg (95 cm2 ) 3,000mg (114 cm2)
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    K Number
    K241866
    Device Name
    InnovaMatrix®FD
    Manufacturer
    Convatec Triad Life Sciences, LLC
    Date Cleared
    2024-07-26

    (29 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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