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510(k) Data Aggregation

    K Number
    K050086
    Device Name
    BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    2006-02-17

    (400 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRENNEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penetration. The dressing may be use for partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Silver Glucan dressings may be used over partial thickness wounds, debrided wounds, and as a temporary covering for full thickness and grafted wounds.
    Device Description
    Silver Glucan dressing consists of a nylon mesh coated with silver and oat glucan. The glucan facilitates the placement of the mesh and the silver protects the wound site from bacterial and yeast contamination. The sterile, single use dressing will be sold in a variety of sizes ranging from 4" x 4" to 16" x 16" and rolls of 4" x 48".
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    K Number
    K030460
    Device Name
    MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    2003-03-07

    (23 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRENNEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.
    Device Description
    (Trade name) is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.
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    K Number
    K021835
    Device Name
    BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    2002-10-17

    (135 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRENNEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Glucamesh™/Glucatex™ Surgical Mesh is intended for the use as a prosthesis in general surgery for surgical treatment of abdominal wall reinforcement, hernia repairs, eventrations, rectal and genitourinary prolapse. The meshes are biocompatible and not biodegradable. The device is intended to be implanted by a qualified surgeon.
    Device Description
    Glucatex mesh is constructed of polypropylene or polyester which is identical in composition to that used in Prolene Soft Mesh, Mersitence or Biomesh. The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth.
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    K Number
    K002077
    Device Name
    GLUCANPRO CREAM
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    2000-10-02

    (84 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRENNEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002078
    Device Name
    BETA GLUCAN GEL (MACROPRO GEL)
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    2000-10-02

    (84 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRENNEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000518
    Device Name
    MACROPRO GEL
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    2000-05-01

    (75 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRENNEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000519
    Device Name
    GLUCANPRO
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    2000-05-01

    (75 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRENNEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982825
    Device Name
    BRENNEN MEDICAL BETA GLUCAN GEL
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    1998-11-06

    (87 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRENNEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Brennen Beta Glucan Gel may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graft sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin. Brennen Glucan Gel provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.
    Device Description
    Brennen Medical Beta Glucan Gel
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    K Number
    K982403
    Device Name
    BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    1998-09-22

    (74 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRENNEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Brennen Biosynthetic Surgical Mesh is indicated in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female winary incontinence resulting from urethral hypermobility or sphincter deficiency.
    Device Description
    Brennen Biosynthetic Surgical Mesh Matrix
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    K Number
    K980962
    Device Name
    BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    1998-07-29

    (135 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRENNEN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MacroPro Cream may be used to aid in the management of superficial and partial thickness burns; pressure ulcers (stages I-IV); venous, diabetic, and arterial ulcers; donor graph sites; superficial through full thickness wounds such as surgical wounds, minor abrasions and lacerations; and irritations of the skin. MacroPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough. For external use only. Do not use on patients with known allergies to plants such as gum oat.
    Device Description
    Brennen Medical Beta Glucan Cream, "MacroPro"
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