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510(k) Data Aggregation

    K Number
    K192667
    Device Name
    gel-e Flex+ gel OTC
    Manufacturer
    gel-e, Inc.
    Date Cleared
    2019-10-25

    (30 days)

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

    gel-e, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    gel-e Flex+ gel OTC is indicated for the local management of bleeding wounds such as minor lacerations and minor abrasions.
    Device Description
    gel-e Flex+ gel OTC is a laboratory tested non-irritating topical chitosan-based gel designed to rapidly (within 30 to 60 seconds) promote hemostasis when in contact with a bleeding wound. Gel-e Flex+ gel OTC is a clear, convenient, and easy to apply gel that can be used with commercially available gauze.
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    K Number
    K182811
    Device Name
    gel-e Flex+
    Manufacturer
    gel-e, Inc.
    Date Cleared
    2019-08-29

    (330 days)

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

    gel-e, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    gel-e Flex+ is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions.
    Device Description
    The gel-e Flex+ (Bandage) is a non-invasive topical bandage intended to control minor bleeding when in contact with a wound by adhering to the site of injury. Based on in vitro testing, the gel-e Flex+ (Bandage) provides an effective barner to bacterial penetration for up to 48 hours. Gel-e Flex+ (Bandage) is composed of a soft, sterile, lyophilized, palmitoyl-N-acetylglucomasine (chitosan), a cellulosic polymer woven fabric pad, attached to a soft adhesive backing. The gel-e Flex+ (Gel) is a topically applied gel intended to control minor bleeding when in contact with a wound. Gel-e Flex+ (Gel) is composed of a semitransparent gel of palmitoyl-N-acetylglucomasine (chitosan), the same cellulosic polymer as the Gel-e Flex+ (Bandage), dissolved in 0.1M lactic acid in water. The lactic acid is present to improve the solubility of chitosan. In vitro testing based on USP<51> has demonstrated the gel-e Flex+ (Gel) remains effectively preserved for up to 28 days after opening the container.
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    K Number
    K180152
    Device Name
    gel-e Flex
    Manufacturer
    gel-e, Inc.
    Date Cleared
    2018-06-22

    (154 days)

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

    gel-e, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    gel-e Flex is indicated for the local management of bleeding such as laceration and minor bleeding.
    Device Description
    The gel-e Flex (Bandage) is a non-invasive topical bandage intended to control minor bleeding when in contact with a wound by adhering to the site of injury. Gel-e Flex (Bandage) is composed of a soft, sterile, lyophilized, palmitoyl- Nacetylglucomasine (chitosan), a cellulosic polymer woven fabric pad, attached to a soft adhesive backing. The gel-e Flex (Gel) is a topically applied gel intended to control minor bleeding when in contact with a wound. Gel-e Flex (Gel) is composed of a semitransparent gel of palmitoyl-N-acetylglucomasine (chitosan), the same cellulosic polymer as the Gel-e Flex (Bandage), dissolved in 0.1M lactic acid in water. The lactic acid is present to improve the solubility of chitosan.
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    K Number
    K172010
    Device Name
    gel-e Bandage
    Manufacturer
    gel-e, Inc. (formerly Remedium Technologies, Inc.)
    Date Cleared
    2017-12-07

    (157 days)

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

    gel-e, Inc. (formerly Remedium Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the gel-e Dressing may be used for management of: - 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 (21 CFR 801 Subpart C): - The gel-e Bandage may be used for the management of: - Minor cuts - Minor scalds and 1st degree burns - Abrasions - Lacerations
    Device Description
    Gel-e Bandage is a sterile topical bandage comprising a lyophilized chitosanbased patch attached to a standard bandage backing with two adhesive strips on either side of the patch for secure attachment to skin. The gel-e Bandage is absorbent and conformable. As wound exudate is absorbed into the chitosanbased patch, the patch forms a gel, which maintains a moist environment for optimal wound healing, and allows intact removal. The gel-e Bandage is intended for use as a primary dressing for a variety of chronic and acute wounds. It secured onto skin by manually pressing the adhesive strips on either side of the patch. Dressings are individually packed into aluminum foil pouches and terminally sterilized to achieve an SAL of 10-6.
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