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510(k) Data Aggregation
Device Name
TheracorManufacturer
Date Cleared
2025-12-22
(83 days)
Product Code
Regulation Number
N/AType
TraditionalAge Range
All
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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