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510(k) Data Aggregation

    K Number
    K981109
    Device Name
    QUITETIP
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    1998-06-09

    (74 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUITETIP

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

    The QuiteTip™ I/A handpiece and tips are used in ophthalmic surgery to provide controlled aspiration of lens tissue while maintaining anterior chamber shape by replacing aspirated fluids with BSS.

    Device Description

    I/A Handpiece and Tips

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Paradigm Medical Industries, Inc., regarding their QuiteTip™ I/A Handpiece and Tips. This document indicates the device has been found substantially equivalent to a predicate device and can be marketed.

    However, the letter does not contain any information about acceptance criteria, performance data, or studies that prove the device meets specific acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a detailed report of a device performance study.

    Therefore, I cannot provide the requested information as it is not present in the given text.

    To answer your request, I would need a document that describes the specific performance studies, their methodology, results, and acceptance criteria for the QuiteTip™ I/A Handpiece and Tips.

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