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510(k) Data Aggregation
K Number
K251845Device Name
Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
Manufacturer
Kerecis Limited
Date Cleared
2025-07-16
(30 days)
Product Code
KGN
Regulation Number
N/AWhy 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
K250329Device Name
GeniPhys Collymer Self-Assembling Scaffold
Manufacturer
GeniPhys, Inc.
Date Cleared
2025-06-25
(140 days)
Product Code
KGN
Regulation Number
N/AWhy 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
K242985Device Name
CollOvine Wound Dressing
Manufacturer
OviGenex LLC
Date Cleared
2025-06-20
(267 days)
Product Code
KGN
Regulation Number
N/AWhy 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
K241904Device Name
DermiSphere Dermal Template
Manufacturer
FesariusTherapeutics Inc.
Date Cleared
2025-01-06
(189 days)
Product Code
KGN
Regulation Number
N/AWhy 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
K243071Device Name
Bovine Dermis Collagen Dermal Matrix
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2024-12-19
(83 days)
Product Code
KGN
Regulation Number
N/AWhy 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
K242146Device 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/AWhy 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
K233378Device Name
ABCcolla® Collagen ADM Scaffold
Manufacturer
ACRO Biomedical Co., Ltd.
Date Cleared
2024-10-18
(382 days)
Product Code
KGN, DAT
Regulation Number
N/AWhy 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
K242828Device Name
Corplex P/ Theracor P/ Allacor P
Manufacturer
StimLabs, LLC
Date Cleared
2024-10-18
(29 days)
Product Code
KGN
Regulation Number
N/AWhy 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
K241080Device Name
Kerecis Parvus (50207)
Manufacturer
Kerecis Limited
Date Cleared
2024-08-21
(124 days)
Product Code
KGN
Regulation Number
N/AWhy 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
K241866Device Name
InnovaMatrix®FD
Manufacturer
Convatec Triad Life Sciences, LLC
Date Cleared
2024-07-26
(29 days)
Product Code
KGN
Regulation Number
N/AWhy 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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