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510(k) Data Aggregation

    K Number
    K173223
    Device Name
    ologen Collagen Matrix
    Manufacturer
    Aeon Astron Europe B.V.
    Date Cleared
    2018-03-02

    (150 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why 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
    K112568
    Device 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/A
    Why 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
    K080868
    Device Name
    AONGEN COLLAGEN MATRIX
    Manufacturer
    AEON ASTRON EUROPE B.V.
    Date Cleared
    2009-05-14

    (412 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why 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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