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510(k) Data Aggregation

    K Number
    K090100
    Device Name
    SOFTSEAL-STF
    Manufacturer
    CHITOGEN, INC.
    Date Cleared
    2009-03-11

    (55 days)

    Product Code
    QSY,FRO,LYA
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K220566
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SoftSeal-STF is indicated for use in the management of bleeding wounds such as skin lacerations, vascular access sites, or percutaneous catheter or tube sites. SoftSeal promotes the rapid control of bleeding for patients on hemodialysis and patients on anticoagulation therapy.

    Device Description

    SoftSeal-STF is a sterile topical pad, packaged in a foil pouch, and sterilized with gamma irradiation to a SAL of 10-6.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (SoftSeal-STF topical hemostasis pad). While it mentions the device's intended use and technological characteristics, it does not include any details about acceptance criteria or a specific study proving the device meets said criteria.

    The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against predefined acceptance criteria.

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