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510(k) Data Aggregation

    K Number
    K971612
    Device Name
    OSMO/PCA PILLOW WOUND DRESSING
    Manufacturer
    PROCYTE CORP.
    Date Cleared
    1998-03-16

    (318 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROCYTE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A highly absorptive pillow dressing for the management of exudating wounds, infected and non-infected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
    Device Description
    Osmo/PCA Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb up to 20 times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the Osmo/PCA Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels. Osmo/PCA Pillow Wound Dressing contains highly absorptive polymer granules able to absorb up to 20 times their weigh in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.
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    K Number
    K972150
    Device Name
    OSMOCYTE ISLAND WOUND DRESSING
    Manufacturer
    PROCYTE CORP.
    Date Cleared
    1997-12-10

    (184 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROCYTE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A self adhesive highly absorptive island dressing for the management of exudating wounds, infected and non-infected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.
    Device Description
    OsmoCyte® Island Wound Dressing utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow attached to a sheet of foam polyurethane and coated with a medical grade acrylic emulsion adhesive.
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    K Number
    K972329
    Device Name
    OSMOCYTE RA WOUND DRESSING
    Manufacturer
    PROCYTE CORP.
    Date Cleared
    1997-12-10

    (170 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROCYTE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Exudating wounds, infected or non-infected including pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions, cuts, abrasions and general first aid.
    Device Description
    OsmoCyte® RA Wound Dressing utilizes a powdered polymer absorbent pad contained in a non-woven mesh pillow attached to a sheet of foam polyurethane and coated with a medical grade acrylic emulsion adhesive.
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    K Number
    K970153
    Device Name
    LAMIN-2 HYDRATING GEL
    Manufacturer
    PROCYTE CORP.
    Date Cleared
    1997-06-05

    (140 days)

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

    PROCYTE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    lamin®-2 Hydrating Gel is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and external contamination.
    Device Description
    lamin®-2 Hydrating Gel acts to provide a moist wound environment and protect the wound. lamin®-2 Hydrating Gel was designed to provide a soothing, moist environment for each application to various types of wounds. lamin®-2 Hydrating Gel Wound Dressing is a low bioburden, preserved preparation of water, glycerin, carbopol (carbomer), prezatide copper acetate and parabens to form a hydrogel dressing.
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    K Number
    K965143
    Device Name
    OSMOCYTE WOUND MANAGER SHEET DRESSING
    Manufacturer
    PROCYTE CORP.
    Date Cleared
    1997-05-22

    (150 days)

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

    PROCYTE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OsmoCyte™ Wound Manager Sheet Dressing is indicated for the management of partial and full thickness wounds, both chronic and acute, with low to moderate exudate, including the following: Pressure ulcers, diabetic ulcers, venous stasis ulcers, arterial ulcers, 18 and 200 degree burns, donor sites, postoperative incisions, minor chemical and thermal burns, superficial lacerations, cuts and abrasions, severe sunburn, dermal lesions (e.g. poison ivy), trauma injuries or incisions.
    Device Description
    A sterile, hydropolymer dressing which protects the wound and provides a moist wound environment for low to moderate exudating wounds.
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    K Number
    K965005
    Device Name
    IAMIN IMPREGNATED GAUZE DRESSING
    Manufacturer
    PROCYTE CORP.
    Date Cleared
    1997-02-24

    (70 days)

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

    PROCYTE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    lamin Impregnated Gauze Dressing is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination.
    Device Description
    lamin® Impregnated Gauze Dressing acts to provide a moist wound environment and protect the wound. lamin® Impregnated Gauze Dressing was designed to provide a soothing, moist environment for each application to various types of wounds as an impregnated gauze dressing. lamin® Impregnated Gauze Dressing is sterile impregnated cotton-blend non-woven gauze.
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    K Number
    K964468
    Device Name
    IAMIN WET DRESSING (COPPER-SALINE)
    Manufacturer
    PROCYTE CORP.
    Date Cleared
    1997-02-03

    (89 days)

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

    PROCYTE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A hydrogel for the dressing and management of both graft recipient and donor sites, postoperative incisions, pressure ulcers, diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment, absorb wound exudate, and protect against abrasion, friction, desiccation, and contamination.
    Device Description
    lamin® Wet Dressing (Copper-Saline) is sterile saturated cotton-blend non-woven gauze.
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    K Number
    K962623
    Device Name
    OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
    Manufacturer
    PROCYTE CORP.
    Date Cleared
    1996-11-26

    (144 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROCYTE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An absorptive pillow dressing for the management of exudating wounds, infected and noninfected, including pressure ulcers, diabetic ulcers, venous stasis ulcers, 1st and 2nd degree burns, donor sites, postoperative incisions, other bleeding surface wounds, dermal lesions, trauma injuries or incisions.
    Device Description
    OsmoCyte™ Ultra/PE Pillow Wound Dressing utilizes the hydrophilic polymer granules contained in a mesh pillow to absorb many times their weight in wound exudate. Since the granules are contained in the mesh pillow, they are easily removed, thereby significantly reducing the possibility of retaining granules within the wound and allowing the OsmoCyte™ Ultra/PE Pillow Wound Dressing to be utilized in wounds with deep cavities or tunnels. OsmoCyte™ Ultra/PE Pillow Wound Dressing contains a highly absorptive polymer able to absorb many times its weight in wound exudate. The granules are encased in an inert low density polyethylene mesh fabric which allow the wound exudate to pass through and be absorbed by the polymer granules but which contains the granules, thus allowing for the dressing's easy removal from cavity or tunnel wounds.
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    K Number
    K953853
    Device Name
    IAMIN GEL WOUND DRESSING
    Manufacturer
    PROCYTE CORP.
    Date Cleared
    1996-02-05

    (173 days)

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

    PROCYTE CORP.

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

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