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510(k) Data Aggregation

    K Number
    K080722
    Device Name
    PRIMADO SURGICAL DRILL
    Manufacturer
    NAKANISHI, INC.
    Date Cleared
    2008-09-17

    (188 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRIMADO SURGICAL DRILL

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

    The Primado is an electrically powered surgical system for delicate bone dissection in the ear, nose and throat areas. A wide range of attachments includes a In the car, dood and chrous, straight/angle/malleable drills, and microsaws.

    Device Description

    The Primado is an electrically powered surgical system.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device conformance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

    The document is an FDA 510(k) clearance letter for the "Primado Surgical Drill," indicating that it has been found substantially equivalent to a legally marketed predicate device. It specifies the intended use of the device and regulatory information but does not contain any performance study details or acceptance criteria for demonstrating that performance.

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