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510(k) Data Aggregation

    K Number
    K991963
    Device Name
    PATTON SPECULUM
    Manufacturer
    PATTON MEDICAL CORP.
    Date Cleared
    1999-09-01

    (83 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K984211,K891351
    Why did this record match?
    Device Name :

    PATTON SPECULUM

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

    The Patton Speculum™ is intended for use to retract the vagina in diagnostic and therapeutic obstetrical and gynecological procedures.

    Device Description

    The Patton Speculum™ is a handheld mechanical device with a pistol-grip handle, four retracting blades, and a ratchet lock. When the handle is squeezed, the blades move in such a way as to expand the cylindrical surface enclosing them.

    AI/ML Overview

    The provided text is a 510(k) summary for the Patton Speculum™. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert involvement, or any form of clinical or technical testing data.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as this information is absent from the provided text. The 510(k) summary focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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