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510(k) Data Aggregation

    K Number
    K991729
    Device Name
    FERRIS POLYOSTOMY STERILE WOUND DRESSING
    Manufacturer
    FERRIS MFG. CORP.
    Date Cleared
    1999-08-27

    (99 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FERRIS POLYOSTOMY STERILE WOUND DRESSING

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

    Ostomy Tube Sites
    Drainage Tube Sites
    Gastrointestinal Tube Sites
    Feeding Tube Sites

    Device Description

    FERRIS POLYOSTOMY STERILE WOUND DRESSING

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "PolyOstomy Sterile Wound Dressing". This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, sample sizes, expert qualifications, or adjudication methods.

    The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical and clinical study data used to establish substantial equivalence. To answer your request, one would typically need access to the actual 510(k) submission, which would include the performance data and supporting studies.

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