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510(k) Data Aggregation

    K Number
    K982659
    Device Name
    MEDIVISION HYSTEROSCOPE
    Manufacturer
    MEDIVISION SCOPE SERVICE CENTER, INC.
    Date Cleared
    1998-10-07

    (69 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDIVISION HYSTEROSCOPE

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

    MEDIVISION HYSTEROSCOPE MV400/MV415/MV430/MV470 INDICATIONS for USE NOTE: Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery. Diagnostic Hysteroscopy - . Abnormal Uterine Bleeding - Infertility & Pregnancy Wastage . - Evaluation of Abnormal Hysterosalpingogram # - Intrauterine Foreign Body - . Amenontiea - Pelvic Pain . - Operative Hysteroscopy - . Directed Blopsy - Removal of Submucous Fibroids and Large Polyps . - . Submucous Myomectorny - . Transection of Intrauterine Adhesions - o Transection of Intrauterine Septa - . Endometrial Ablation Medical disease, cervical stenosis, and pelvic infection may alter the choice of location for hysteroscopy {i.e., office setting vs. Hospital),

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Medivision Hysteroscopes. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it confirms that the device is substantially equivalent to a predicate device already on the market.

    Therefore, I cannot provide the requested information.

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