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510(k) Data Aggregation

    K Number
    K060129
    Device Name
    IGS VAGINAL SPECULUM
    Manufacturer
    INNOVATIVE GYNECOLOGICAL SOLUTIONS LLC
    Date Cleared
    2006-05-04

    (106 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIVE GYNECOLOGICAL SOLUTIONS LLC

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

    The IGS Vaginal Speculum is indicated to provide access to the cervix.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA to a medical device company regarding a 510(k) premarket notification for a vaginal speculum. It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

    This document does not contain information on acceptance criteria, reported device performance, study designs, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or how ground truth was established.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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