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510(k) Data Aggregation

    K Number
    K974228
    Device Name
    HOSPITAL'S SPEC
    Manufacturer
    GPS
    Date Cleared
    1997-12-12

    (30 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DISPOSABLE STERILE VAGINAL SPECULUM USED TO EXAMINE THE INTERIOR OF THE VAGINA DURING GYNECOLOGICAL PROCEDURES HAS A REGULATING SCREW TO ALLOW A GRADUAL OPENING

    Device Description

    Vaginal Speculum

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Vaginal Speculum (HOSPITAL'S SPEC). It does not contain information about acceptance criteria or a study proving the device meets said criteria.

    The letter states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This means the FDA determined the device is as safe and effective as a legally marketed predicate device, rather than requiring a new study with specific acceptance criteria.

    Therefore, the requested information cannot be extracted from the provided text. The document is primarily a regulatory communication confirming that the device can be legally marketed.

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