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510(k) Data Aggregation

    K Number
    K242828
    Device Name
    Corplex P/ Theracor P/ Allacor P
    Manufacturer
    StimLabs, LLC
    Date Cleared
    2024-10-18

    (29 days)

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

    StimLabs, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Corplex P/Theracor P/Allacor P is indicated for use in the management of the following wounds: - · Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - · Diabetic ulcers - · Chronic vascular ulcers - · Tunneled/undermined wounds - · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) - · Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears) - · Draining wounds
    Device Description
    Corplex P/Theracor P/Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
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    K Number
    K231325
    Device Name
    Corplex P / Theracor P / Allacor P
    Manufacturer
    StimLabs, LLC
    Date Cleared
    2024-02-02

    (270 days)

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

    StimLabs, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Corplex P/Theracor P/Allacor P is indicated for use in the management of the following wounds: - Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - Diabetic ulcers - Chronic vascular ulcers - Tunneled/undermined wounds - Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence) - Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears) - Draining wounds
    Device Description
    Corplex P/Theracor P/Allacor P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
    Ask a Question

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