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510(k) Data Aggregation

    K Number
    K011618
    Device Name
    CALGITROL AG SILVER ALGINATE WOUND DRESSING
    Manufacturer
    ADRI
    Date Cleared
    2002-11-15

    (539 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CALGITROL AG SILVER ALGINATE WOUND DRESSING

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

    Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers 1st and 2nd degree burns; donor sites

    Device Description

    CALGITROL™ Ag Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Calgitrol™ AG Silver Alginate Foam and Gel Foam Dressings). This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory approval letter, not a study report.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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