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510(k) Data Aggregation

    K Number
    K212766
    Device Name
    Maxiocel Chitosan Wound Dressing
    Manufacturer
    Advamedica Inc.
    Date Cleared
    2023-08-24

    (723 days)

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

    Advamedica Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration. Under medical supervision, the Maxiocel Chitosan Wound Dressing may be used for the management of the following wounds: Pressure sores, Diabetic ulcers, Leg ulcers, Donor sites and graft sites, Surgical wounds, Skin abrasions and lacerations, 1st and 2nd degree burns, Trauma wounds. Over-the-counter use: The Maxiocel Chitosan Wound Dressing is indicated for the management of Minor cuts, Minor scalds and 1st-degree burns, Abrasions, Lacerations and to provide a barrier against bacterial penetration.
    Device Description
    The Maxiocel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing is provided both in prescription (Rx) and over-the-counter (OTC) forms. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days. Dressings are individually packed in moisture-proof pouches and terminally sterilized using gamma radiation to achieve a SAL 10t. The Maxiocel Chitosan Wound Dressing can be manufactured in different sizes and are currently available in the following sizes. 18" x 18" (45 cm x 45 cm), 8"x 12" (20 cm x 30cm), 6" x 6" (15 cm x 15 cm), 4" x 4" (10 cm x 10 cm), 2" x 4" (5 cm x 10 cm), 2"x 2" (5 cm x 5cm), 1"x2" (2.5 cm x 5cm), 1"x1" (2.5 cm x 2.5 cm), 1" x 12" (2.5 cm x 30 cm).
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    K Number
    K222909
    Device Name
    Axiostat Gauze
    Manufacturer
    Advamedica Inc.
    Date Cleared
    2023-04-07

    (193 days)

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

    Advamedica Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prescription: The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. Over-the-Counter: The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
    Device Description
    The Axiostat Gauze is a single-use, non-absorbable non-woven hemostatic gauze. It is made of non-woven fabric derived from chitosan, which is a natural polymer. Chitosan is known for its mucoadhesive and hemostatic properties. When applied directly to a wound the dressing controls bleeding and can be removed after the clotting has occurred. The dressing should be removed within 24 hours. The dressing is not intended to be implanted. The Axiostat Gauze is individually packed in a moisture proof packaging and terminally sterilized by gamma radiation to a sterility assurance level (SAL) of 10-6.
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    K Number
    K213198
    Device Name
    Ax-Surgi Surgical Hemostat
    Manufacturer
    Advamedica Inc.
    Date Cleared
    2023-01-05

    (463 days)

    Product Code
    POD
    Regulation Number
    878.4454
    Why did this record match?
    Applicant Name (Manufacturer) :

    Advamedica Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ax-Surgi is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.
    Device Description
    The Ax-Surgi Surgical Hemostat Surgical Hemostat is a sterile, single-use, surgical hemostatic patch. It is composed of a soft, lyophilized chitosan pad attached to a standard viscose-polyester gauze with a radiopaque element.
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    K Number
    K202830
    Device Name
    Axiostat Patch
    Manufacturer
    Advamedica Inc.
    Date Cleared
    2021-04-15

    (202 days)

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

    Advamedica Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites. vascular procedure sites and sites involving percutaneous catheters, tubes and pins.
    Device Description
    The Axiostat Patch is a sterile, single use, non-absorbable hemostatic dressing. It is composed of chitosan a well-known natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied directly to a wound with firm pressure, the dressing controls bleeding and provides a barrier against bacterial penetration. The hemostatic dressing can be removed after the clotting has occurred but should not remain on for more than 24 hours. The hemostatic dressing is not intended to be implanted. The Axiostat Patch is individually packaged in moisture proof packs and terminally sterilized using gamma irradiation.
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    K Number
    K172324
    Device Name
    Axiostat Chitosan Hemostatic Dressing
    Manufacturer
    Advamedica Inc.
    Date Cleared
    2018-02-23

    (206 days)

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

    Advamedica Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Axiostat Chitosan Hemostatic Dressing is indicated to control bleeding of lacerations, minor cuts and abrasions.
    Device Description
    Axiostat is a single use, hemostatic dressing made of 100% chitosan is a wellknown natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied on the bleeding site with firm pressure, the Axiostat Chitosan Hemostatic Dressing acts as a mechanical barrier against bleeding. The Axiostat is intended for a maximum duration of use of 24 hours, including bandage changes that may be needed. Axiostat is individually packaged in foil bags and sterilized using gamma irradiation. Axiostat is provided in six different sizes for over the counter use as listed below.
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