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510(k) Data Aggregation

    K Number
    K974890
    Device Name
    ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
    Manufacturer
    ACUTEK ADHESIVE SPECIALTIES, INC.
    Date Cleared
    1998-10-13

    (287 days)

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

    ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002

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

    The Hydrocolloid Dressing is intended for the management of lightly to moderately exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document does not contain information about acceptance criteria or a study proving device performance. This is a 510(k) clearance letter from the FDA for a wound dressing, indicating that the device is substantially equivalent to a predicate device and can be marketed. It outlines the indications for use and certain labeling restrictions.

    Therefore, I cannot provide the requested table or answer the specific questions about a study and its details as they are not present in the provided text.

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