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510(k) Data Aggregation

    K Number
    K251826
    Date Cleared
    2025-09-11

    (90 days)

    Product Code
    Regulation Number
    878.4780
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K243576

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is intended to be used in conjunction with Smith+Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS systems. The Smith+Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Appropriate wound types for RENASYS WOUND+ Dressing include:

    • Chronic
    • Acute
    • Traumatic
    • Sub-Acute and dehisced wounds
    • Ulcers (such as pressure or diabetic)
    • Partial-thickness burns
    • Flaps
    • Grafts

    RENASYS WOUND+ Dressing without filler can be used on the following additional wound type:

    • Closed surgical incisions

    The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology in Small, Medium, and Large sizes is intended to be used with Smith+Nephew RENASYS TOUCH, RENASYS GO, and RENASYS EDGE NPWT systems.

    Device Description

    RENASYS WOUND+ Dressing kits with AIRLOCK Technology can be used without a wound filler, with foam or with gauze wound filler. The kits are accessories intended for use in conjunction with RENASYS TOUCH, RENASYS GO and RENASYS EDGE Negative Pressure Wound Therapy systems. RENASYS Negative Pressure Wound Therapy allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

    AI/ML Overview

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