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510(k) Data Aggregation

    K Number
    K253339

    Validate with FDA (Live)

    Device Name
    Theracor
    Manufacturer
    Date Cleared
    2025-12-22

    (83 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Theracor is intended to cover, protect, and provide a moist wound environment.

    Theracor 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

    Theracor is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. The device is intended to cover, protect, and provide a moist wound environment. As a resorbable device, Theracor is aseptically processed and lyophilized to remove moisture while preserving the structural components of the umbilical cord matrix. The device is packaged in sheet form and should be rehydrated prior to applying to the wound bed.

    AI/ML Overview

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