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510(k) Data Aggregation

    K Number
    K982439
    Device Name
    PROXIDERM, MODELS TN 460, TN 90 460, BK 460
    Manufacturer
    PROGRESSIVE SURGICAL PRODUCTS, INC.
    Date Cleared
    1998-09-08

    (56 days)

    Product Code
    MKY
    Regulation Number
    878.4320
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROXIDERM, MODELS TN 460, TN 90 460, BK 460

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

    The Proxiderm is intended to be utilized prior to a surgical procedure to remove a defect or prior to implantation of a prosthesis to provide additional skin for coverage of the defect or prosthesis.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for a device called "Proxiderm." The letter states that the device is substantially equivalent to legally marketed predicate devices. However, the provided document does not contain any information about acceptance criteria, device performance, studies, sample sizes, expert qualifications, or ground truth.

    Therefore, I cannot provide the requested table and study details. This document is a regulatory clearance, not a technical report or scientific study summary.

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