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510(k) Data Aggregation
K Number
K173223Device Name
ologen Collagen Matrix
Manufacturer
Aeon Astron Europe B.V.
Date Cleared
2018-03-02
(150 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Aeon Astron Europe B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ologen™ Collagen Matrix is intended for the management of wounds including: surgical wounds, trauma wounds, second degree burns, partial and full-thickness wounds, pressure ulcers, venous ulcers, vascular ulcers, diabetic ulcers, oral wounds and sores.
Device Description
ologen™ Collagen Matrix (K173223) proposed device has 9 models which differ in sizes and shapes but with the same composition. Different specifications are all intended for wound dressing. Which specification should be applied is determined by the physician according to the size, depth, location, type of wound and his/hers preference. The lists the specifications and shapes of all 9 models refer to Instruction for Use.
single-use sterile
Environment of Use: healthcare facility/hospital
ologen™ Collagen Matrix is a biodegradable material composed of collagen. It is indicated for the management of wounds. ologen™ Collagen Matrix is obtained from porcine hide and the matrix structure has a porous configuration made of ≥90% cross-linked lyophilized porcine collagen and <10% glycosaminoglycans (GAG).
This device is sterile (gamma sterilization) and for single use only. ologen™ Collagen Matrix should only be opened under sterile conditions and handled using standard aseptic techniques.
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K Number
K112568Device Name
AONGEN DENTAL COLLAGEN MATRIX
Manufacturer
AEON ASTRON EUROPE B.V.
Date Cleared
2012-03-01
(177 days)
Product Code
OLR, MQN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
AEON ASTRON EUROPE B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aongen™ Dental is intended for use in dental surgical procedures as a resorbable material for open wounds to aid in wound healing post surgery.
Device Description
Aongen™ Dental Collagen Matrix is a white, resorbable matrix manufactured from porcine type I collagen and glycosaminoglycan. The function of glycosaminoglycan is water absorption. The device is supplied sterile and for single use only. Aongen™ Dental Collagen Matrix functions in a manner similar to the predicates.
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K Number
K080868Device Name
AONGEN COLLAGEN MATRIX
Manufacturer
AEON ASTRON EUROPE B.V.
Date Cleared
2009-05-14
(412 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
AEON ASTRON EUROPE B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aongen™ Collagen Matrix is intended for the management of wounds including:
- . surgical wounds
- trauma wounds t
- draining wounds .
- . second degree burns
- partial and full-thickness wounds .
- . pressure ulcers
- . venous ulcers
- vascular ulcers .
- . diabetic ulcers
- oral wounds and sores .
Device Description
The Aongen™ Collagen Matrix is a biodegradable material composed of collagen. It is indicated for the management of wounds. The device is supplied sterile and for single use only.
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