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510(k) Data Aggregation

    K Number
    K992005
    Device Name
    GILTECH PLUS TRANSPARENT DRESSING
    Manufacturer
    GILTECH PLUS, INC.
    Date Cleared
    1999-09-03

    (80 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 :

    GILTECH PLUS TRANSPARENT DRESSING

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

    The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as:

    (a) Stage I and II pressure sores (decubitus ulcers)

    (b) Skin tears or lacerations

    (c) Superficial burns and abrasions

    (d) Surgical wounds

    Device Description

    Transparent Dressing

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called "Giltech Plus Transparent Dressing." This document addresses the substantial equivalence of the device and its indications for use, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based on the input text. The document is strictly a regulatory clearance and does not delve into the technical details of device validation.

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