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510(k) Data Aggregation

    K Number
    K972336
    Device Name
    DERMAMEND HYDROGEL GAUZE DRESSING
    Manufacturer
    DERMARX CORP.
    Date Cleared
    1997-07-29

    (36 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To absorb exudate and to create and maintain a moist environment for partial and full thickness wounds including pressure ulcers, stage I-V; stasis ulers; dermal wounds; 1ª and 2ª degree burns; cuts, abrasions, and other imitations of the skin.

    Device Description

    DermaMend™ Hydrogel Gauze Dressing

    AI/ML Overview

    This document is a 510(k) clearance letter for the DermaMend™ Hydrogel Gauze Dressing. It indicates that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing summaries.

    Instead, it specifies limitations on the device's labeling and claims based on its classification and the 510(k) review process. These limitations effectively act as "negative acceptance criteria" for marketing claims.

    As a result, I cannot provide the requested information from the provided text. The tables and other requested details regarding acceptance criteria, study design, sample sizes, ground truth, experts, and comparative effectiveness are not present in this regulatory clearance letter.

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