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510(k) Data Aggregation

    K Number
    K971518
    Device Name
    KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1997-07-24

    (90 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KSEA Semi-Rigid Hysteroscope and Accessories are designed to view the uterus, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken Motion Control Device attaches to an instrument channel to precisely guide the introduction of small instrument into the patient.

    The Karl Storz Semi-Rigid Hysteroscope and Accessories are indicated in the following conditions:

    Diagnostic
    infertility and pregnancy wastage abnormal uterine bleeding intrauterine foreign body pelvic pain monitoring of IUD status evaluation of abnormal hysterosalpingogram evaluation of abnormalities of the endometrium

    Operative
    directed biopsy transection of intrauterine septa transection of intrauterine adhesions

    Absolute Contraindications for Use: acute PID

    Relative Contraindications for Use:
    inability to distend uterus cervical/vaginal infection known pregnancy uterine bleeding or menses invasive carcinoma of the cervix recent uterine perforation medical contraindication intolerance to anesthesia cervical stenosis

    Device Description

    The KSEA Semi-Rigid Hysteroscope is a straight, graduated shaft endoscope with a remote eyepiece. The Alken Motion Control Device is an attachment to the instrument channel to control the introduction and movement of accessories. All devices are manually operated, reusable surgical devices. Body contact materials are stainless steel (chromium-plated Monel 400®).

    AI/ML Overview

    This document is a 510(k) Summary of Safety and Effectiveness for a Semi-Rigid Hysteroscope and Accessories. It seeks to demonstrate substantial equivalence to predicate devices, not to present a study with acceptance criteria and device performance. Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

    This document describes a medical device (Semi-Rigid Hysteroscope and Accessories) and its intended use, focusing on demonstrating substantial equivalence to existing legally marketed devices. It is a regulatory submission, not a study report.

    Therefore, I cannot populate the requested sections as the information is not present in the provided text.

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