BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS

    K Number: K031622 · Decision Jun 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    7
    Review Days
    34

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    Basic Information

    Device Name
    WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
    K Number
    K031622
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Portex , Ltd.
    Date Received
    May 23, 2003
    Decision Date
    June 26, 2003
    Product Code
    MQE
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQE Needle, Assisted Reproduction

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    Other Clearances by Portex , Ltd.

    K Number Device Name
    K040014 PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
    K032112 P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
    K033084 WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
    K032716 PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)
    K030570 BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
    K030381 PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA