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510(k) Data Aggregation

    K Number
    K250115
    Device Name
    Hemastyl(™) Wound Dressing
    Manufacturer
    Rapid Nexus Nanotech Wound Solutions, Inc.
    Date Cleared
    2025-10-14

    (271 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K172747,K090453,K071552,K180643,K083103
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K172747, K090453, K071552, K180643

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

    The Hemastyl Wound Gel is indicated for use as follows:

    Hemastyl Wound Gel

    Rx: Management of wounds such

    • 1st degree burns and 2nd degree superficial burns
    • stasis ulcers
    • pressure ulcers
    • diabetic ulcers
    • lacerations
    • abrasions
    • skin tears
    • surgical incision sites
    • device insertion site wounds
    • graft sites
    • donor sites

    OTC: Management of minor cuts, minor abrasions, minor lacerations and minor scalds.

    Device Description

    Hemastyl™ Wound Dressing is a repeat use, amorphous hydrogel containing silver chloride (AgCl), cupric chloride (CuCl2) and ferric chloride (FeCl3) as preservatives and HA and fish collagen for use in the management of wounds.

    AI/ML Overview

    N/A

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